10.1007/s11060-009-0038-7</TIT= LE> <META content=3D"text/html; charset=3DISO-8859-1" = http-equiv=3DContent-Type><LINK=20 rel=3DstyleSheet type=3Dtext/css=20 href=3D"http://www.springerlink.com/config/css/A++_common.css"><LINK=20 rel=3DstyleSheet type=3Dtext/css=20 href=3D"http://www.springerlink.com/config/css/content_A++_SpringerLink.c= ss"> <META name=3DGENERATOR content=3D"MSHTML 8.00.6001.18852"></HEAD> <BODY class=3Dfor-print> <TABLE border=3D1 cellPadding=3D2> <TBODY> <TR class=3Dheader> <TD>Journal of Neuro-Oncology</TD></TR> <TR> <TD>=A9 Springer Science+Business Media, = LLC. 2009</TD></TR> <TR> <TD>10.1007/s11060-009-0038-7</TD></TR></TBODY></TABLE> <H2 class=3Drubric>Clinical Study - Patient Study</H2> <DIV class=3DHeading1><A name=3Dtitle></A>Compartmental intrathecal=20 radioimmunotherapy: results for treatment for metastatic CNS = neuroblastoma=20 </DIV> Kim Kramer1 <A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#ContactOfAuthor1"><IMG=20 border=3D0 alt=3D"Contact Information"=20 src=3D"http://www.springerlink.com/content/p07804022q60v008/contact.gif">= </A>,=20 Brian H. Kushner1, Shakeel Modak1,=20 Neeta Pandit-Taskar2, = Peter Smith-Jones2,=20 Pat Zanzonico3, John L. Humm3,=20 Hong Xu1, Suzanne L. Wolden4,=20 Mark M. Souweidane5, = Steven M. Larson2=20 and Nai-Kong V. Cheung1 <TABLE> <TBODY> <TR vAlign=3Dtop> <TD><A = name=3DAff1></A>(1) </TD> <TD>Department of Pediatrics, Memorial=20 Sloan-Kettering Cancer Center, 1275 York Avenue, Box 429, New = York,=20 NY 10065, USA</TD></TR></TBODY></TABLE> <TABLE> <TBODY> <TR vAlign=3Dtop> <TD><A = name=3DAff2></A>(2) </TD> <TD>Department of Nuclear Medicine, = Memorial=20 Sloan-Kettering Cancer Center, New York, NY 10065,=20 USA</TD></TR></TBODY></TABLE> <TABLE> <TBODY> <TR vAlign=3Dtop> <TD><A = name=3DAff3></A>(3) </TD> <TD>Department of Medical Physics, = Memorial=20 Sloan-Kettering Cancer Center, New York, NY 10065,=20 USA</TD></TR></TBODY></TABLE> <TABLE> <TBODY> <TR vAlign=3Dtop> <TD><A = name=3DAff4></A>(4) </TD> <TD>Department of Radiation Oncology, = Memorial=20 Sloan-Kettering Cancer Center, New York, NY 10065,=20 USA</TD></TR></TBODY></TABLE> <TABLE> <TBODY> <TR vAlign=3Dtop> <TD><A = name=3DAff5></A>(5) </TD> <TD>Department of Neurosurgery, Memorial=20 Sloan-Kettering Cancer Center, New York, NY 10065,=20 USA</TD></TR></TBODY></TABLE> <A name=3DContactOfAuthor1></A> <TABLE class=3DContact> <TBODY> <TR> <TD vAlign=3Dtop><IMG border=3D0 alt=3D"Contact Information"=20 = src=3D"http://www.springerlink.com/content/p07804022q60v008/contact.gif">= </TD> = <TD>Kim Kramer<BR= >Email:=20 <A=20 = href=3D"mailto:Kramerk@mskcc.org">Kramerk@mskcc.org</A></TD></TR></TBODY>= </TABLE> Received:=20 3 June 2009 Accepted:=20 12 October 2009 Published online:=20 5 November 2009 <DIV class=3DAbstract><A name=3DAbs1></A><SPAN=20 class=3DAbstractHeading>Abstract Innovation in the = management of=20 brain metastases is needed. We evaluated the addition of compartmental=20 intrathecal antibody-based radioimmunotherapy (cRIT) in patients with = recurrent=20 metastatic central nervous system (CNS) neuroblastoma following surgery, = craniospinal irradiation, and chemotherapy. Twenty one patients treated = for=20 recurrent neuroblastoma metastatic to the CNS, received a = cRIT-containing=20 salvage regimen incorporating intrathecal 131I-monoclonal = antibodies=20 (MoAbs) targeting GD2 or B7H3 following surgery and radiation. Most = patients=20 also received outpatient craniospinal irradiation, 3F8/GMCSF = immunotherapy,=20 13-cis-retinoic acid and oral temozolomide for systemic control.=20 Seventeen of 21 cRIT-salvage patients are alive 7=9674 months = (median 33=20 months) since CNS relapse, with all 17 remaining free of CNS = neuroblastoma. One=20 patient died of infection at 22 months with no evidence of disease = at=20 autopsy, and one of lung and bone marrow metastases at 15 months, = and one=20 of progressive bone marrow disease at 30 months. The cRIT-salvage = regimen was=20 well tolerated, notable for myelosuppression minimized by stem cell = support=20 (n =3D 5), and biochemical hypothyroidism=20 (n =3D 5). One patient with a 7-year history of = metastatic=20 neuroblastoma is in remission from MLL-associated secondary leukemia. = This is=20 significantly improved to published results with non-cRIT based where = relapsed=20 CNS NB has a median time to death of approximately 6 months. The=20 cRIT-salvage regimen for CNS metastases was well tolerated by young = patients,=20 despite their prior history of intensive cytotoxic therapies. It has the = potential to increase survival with better than expected quality of = life. </DIV> <SPAN=20 class=3DKeywordHeading>Keywords Neuroblastoma -&nb= sp;Radioimmunotherapy - CNS=20 metastases - Intrathecal <DIV class=3DFulltext> <DIV><A name=3DSec1></A> <HR> <DIV class=3Dheading2>Introduction</DIV> Neuroblastoma (NB) is the most common extracranial solid tumor in = children.=20 Recurrent metastatic NB is difficult to cure, particularly in patients = with=20 central nervous system (CNS) disease [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR1">1</A></CITE>].=20 The CNS has emerged as a sanctuary site leading to relapse. Among large = series,=20 the incidence of leptomeningeal (LM) or CNS parenchymal disease in = relapsed=20 patients is 6=968% [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR2">2</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR3">3</A></CITE>].=20 CNS relapses have been almost always fatal [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR1">1</A></CITE>=96<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR3">3</A></CITE>]=97hence=20 the need for innovative treatments. Compartmental radioimmunotherapy = (cRIT)=20 using radioiodinated monoclonal antibodies (MoAbs) administered = intrathecally=20 results in a favorable cerebrospinal fluid (CSF) to blood activity=20 concentrations and radiation dose ratios and may be useful in the = treatment of=20 LM disease [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR4">4</A></CITE>=96<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR6">6</A></CITE>].=20 For example, cRIT using 131I-labeled murine anti-tenascin = MoAbs in=20 patients with malignant glioma was feasible, well tolerated and improved = survival [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR7">7</A></CITE>=96<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR9">9</A></CITE>].=20 A phase I study at Memorial Sloan-Kettering Cancer Center (MSKCC)=20 demonstrated the feasibility of cRIT for patients with GD2-expressing LM = neoplasms using the anti-GD2 murine MoAb 3F8 labeled with = 131I=20 [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR10">10</A></CITE>].=20 Another murine MoAb, 8H9, is specific for 4Ig-B7H3, a 58 kD surface=20 immunomodulatory glycoprotein that inhibits natural killer cells and T = cells.=20 The B7-H3 protein is distributed on the cell membrane of a broad = spectrum of=20 pediatric and adult solid tumors, preferentially expressed on tumors as = compared=20 to normal human tissues [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR11">11</A></CITE>].=20 When radiolabeled with 131I, 8H9 can deliver therapeutic = doses of=20 radiation to solid tumors and suppress tumor cell growth in established=20 xenografts [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR12">12</A></CITE>].=20 We now report the survival of patients with relapsed CNS NB treated with = a=20 cRIT-based salvage regimen targeting minimal residual disease. = </DIV> <DIV><A name=3DSec2></A> <HR> <DIV class=3Dheading2>Methods</DIV> Staging was carried out according to the International Neuroblastoma = Staging=20 System [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR13">13</A></CITE>].=20 CNS NB was defined as LM disease or metastatic deposits in the CNS = parenchyma=20 excluding skull bone-based metastases. The disease was confirmed = pathologically=20 in 20 patients, and radiographically in 1 patient with numerous = enhancing=20 masses. <DIV><A name=3DSec3></A> <DIV class=3DHeading3>Overall treatment plan</DIV> <DIV class=3DPara> <DIV>The overall salvage regimen in 17 patients from July 2003 through = March=20 2009 is summarized in Table <A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#Tab1">1</A>.=20 Parenchymal CNS disease was immediately resected when possible, with = concurrent=20 placement of an intraventricular Ommaya catheter to deliver intrathecal = therapy.=20 Craniospinal irradiation (1080=962160 cGy) was delivered in twice = daily=20 fractions over a 3 week period, with a boost to parenchymal masses = (up to=20 3000 cGy total) when possible. Craniospinal irradiation was = delivered in=20 the outpatient setting in conjunction with a course of irinotecan = followed by a=20 course of irinotecan-temozolomide =B1 carboplatin [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR14">14</A></CITE>].=20 The resulting myelosuppression was reversed by infusion of previously = collected=20 peripheral blood stem cells when necessary. Consolidation with cRIT then = began=20 (see below). After completing the cRIT protocol, outpatient maintenance = systemic=20 therapy consisted of immunotherapy using intravenous 3F8 plus=20 granulocyte=96macrophage colony-stimulating factor (GM-CSF) as = previously=20 described [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR15">15</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR16">16</A></CITE>],=20 oral 13-cis-retinoic acid [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR17">17</A></CITE>],=20 and oral temozolomide [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR18">18</A></CITE>].=20 This study was approved by MSKCC IRB, and informed written consents for = all=20 treatments were obtained from guardians prior to treatment after they = understood=20 the potential side-effects of each agent and the possibility of = unforeseen=20 toxicities.<A name=3DTab1></A> <DIV class=3DCapt>Table 1 General = cRIT-based=20 treatment plan for patients with relapsed CNS NB </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dleft></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft> Time</TH> <TH align=3Dleft> Intervention</TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft> Day 0</TD> <TD align=3Dleft> Resection of CNS disease when possible; Ommaya catheter=20 placement</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Day 7</TD> <TD align=3Dleft> Irinotecan 50 mg/m2/dose IV daily =D75 = </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Day 14</TD> <TD align=3Dleft> Craniospinal irradiation 1080=962160 cGy/boost=20 2560=963000 cGy</TD></TR> <TR class=3Dnoclass> <TD rowSpan=3D4 align=3Dleft> Week 7</TD> <TD align=3Dleft> Irinotecan 50 mg/m2/dose IV daily =D75 = </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Temozolamide 250 mg/m2/dose daily =D75 = </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Carboplatin 500 mg/m2/dose daily =D72 (only if = systemic=20 NB present) </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Stem cell rescuea </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Week 14</TD> <TD align=3Dleft> Serial injections of intra-Ommaya 131I-MoAbs = </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Week 30</TD> <TD align=3Dleft> GMCSF/IV 3F8 every 3=964 weeks (4 cycles)</TD></TR> <TR class=3Dnoclass> <TD rowSpan=3D2 align=3Dleft> Weeks 40=96104</TD> <TD align=3Dleft> Oral cis-retinoic acid=20 160 mg/m2 day =D7 14 days (6 = cycles)=20 alternating with </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Oral temozolomide = 75 mg/m2/day =D7 42 days=20 (5 cycles) </TD></TR></TBODY></TABLE> <DIV class=3DCapt> <DIV class=3DCaptCont> <DIV>3F8=97monoclonal anti-GD2 antibody</DIV></DIV> <DIV class=3DCaptCont> <DIV>aIf needed; MoAbs monoclonal antibodies, = GMCSF=20 granulocyte macrophage colony stimulating factor=20 </DIV></DIV></DIV></DIV></DIV></DIV> <DIV><A name=3DSec4></A> <DIV class=3DHeading3>cRIT treatment</DIV> Patients were enrolled into a protocol testing cRIT, = 131I-3F8=20 (n =3D 3, NCT00445965), or 131I-8H9=20 (n =3D 11, NCT00089245) for individuals with high-risk = metastatic=20 CNS tumors. The decision to use 3F8 or 8H9 was dependent on protocol=20 opening/timing (intrathecal 131I-3F8 was the first available=20 antibody) and systemic disease status (intrathecal 131I-3F8 = allowed=20 for two cycles of systemic chemotherapy between injections). Homogenous=20 reactivity to 3F8 [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR19">19</A></CITE>]=20 and 8H9 [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR11">11</A></CITE>]=20 on neuroblastoma tumors has previously been demonstrated and was not = required at=20 study entry. Eligible patients had no rapidly deteriorating neurologic=20 examination or obstructive hydrocephalus, had an absolute neutrophil = count=20 >1000/=B5l, platelet count >50,000/=B5l, blood urea nitrogen=20 <30 mg/dl, serum bilirubin <3.0 mg/dl, and serum = creatinine=20 <2 mg/dl. Ommaya catheter position, patency and CSF flow were = evaluated=20 by pre-treatment 111-Indium diethylene triamine pentaacetic acid (DTPA) = studies.=20 Patients had baseline magnetic resonance imaging (MRI) studies of the = brain and=20 spinal cord and CSF cytology examination approximately 1 month = prior to and=20 after cRIT. MoAbs 3F8 and 8H9 were purified and radiolabeled at MSKCC using = iodogen=20 [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR20">20</A></CITE>]=20 according to specifications detailed in the respective investigational = new drug=20 applications, averaging 5 mCi/mg 3F8 or 8H9. Patients received an = oral=20 saturated solution of potassium iodide and liothyronine to suppress = thyroid=20 function and were premedicated with acetaminophen, lorazepam and=20 diphenhydramine. Intra-Ommaya treatment comprised: (a) an injection of = 131I-3F8=20 (10 mCi) every 2=963 weeks for a total of four injections = (total dose=20 40 mCi) based on the MTD established on a phase I study [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR10">10</A></CITE>]=20 or (b) 1 or 2 monthly injections 131I-8H9 = (10=9660 mCi/injection).=20 Dosing was based on the treatment plan on the phase II study (3F8) or = the phase=20 I dose escalation level (8H9) at the time of patient entry. Dose = adjustments=20 based on CSF volume were made for patients less than 3 years of age = (<12 months, 50% dose reduction; 13=9636 months, 33% dose = reduction;=20 >36 months, full dose). Clinical status, vital signs and = neurologic=20 examination were monitored overnight. Repeat injections were = administered in the=20 absence of grade 3 or 4 toxicity using the National Cancer Institute = Common=20 Toxicity Criteria [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR21">21</A></CITE>].=20 Upon completion of the cRIT protocol, CNS and systemic disease status = was=20 assessed approximately every 3 months by CT of the primary site, = MRI brain=20 and spine, 123I-meta-iodobenzylguanidine (MIBG) scans, = multiple bone=20 marrow aspirations and biopsies, CSF cytology and urine catecholamine = analyses.=20 </DIV> <DIV><A name=3DSec5></A> <DIV class=3DHeading3>Dosimetry</DIV> <DIV class=3DPara> <DIV>Pre-treatment dosimetry was obtained by 2 mCi of = 131I- or=20 more recently 124I-MoAbs, followed by serial whole body = Single Photon=20 Emission Computerized Tomography (SPECT) or Positron Emission Tomography = (PET)=20 scans, respectively. Distribution and activity concentrations of = radioactivity=20 in the craniospinal axis, and radiation doses to plaques of disease and=20 surrounding normal tissues were determined (Fig. <A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#Fig1">1</A>).=20 131I-MoAb radiation doses for target organs including CSF,=20 ventricles, spinal cord, normal brain and blood were based on the = assumption of=20 complete local absorption of the 131I beta radiation.=20 <DIV class=3DFigure><A name=3DFig1></A><IMG=20 alt=3DMediaObjects/11060_2009_38_Fig1_HTML.gif=20 src=3D"http://www.springerlink.com/content/p07804022q60v008/MediaObjects/= 11060_2009_38_Fig1_HTML.gif"></DIV> <DIV class=3DCapt>Fig. 1 = 124I-8H9=20 Positron Emission Tomography Scan obtained 48 hours post = Intra-Ommaya=20 injection demonstrating distribution throughout the thecal space and = activity=20 within leptomeningeal deposits </DIV> <HR> </DIV></DIV> Injections were followed by pharmacokinetic studies in CSF and blood. = Measured aliquots were counted to estimate the time-dependent activity=20 concentrations. The respective time-activity data were fit to = exponential=20 functions, which were integrated to yield the decayed area under the = curves=20 (AUCs), representing the cumulative activity concentrations in the blood = and CSF=20 as previously described [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR10">10</A></CITE>].=20 </DIV></DIV> <DIV><A name=3DSec6></A> <HR> <DIV class=3Dheading2>Results</DIV> <DIV class=3DPara> <DIV>Tables <A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#Tab2">2</A>=20 and <A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#Tab3">3</A>=20 present the clinical characteristics and demographics of the 21 patients = who=20 received this salvage regimen of surgery, craniospinal irradiation,=20 chemotherapy, and intra-Ommaya 131I-MoAb-therapy. Only 13 = (62%) of 21=20 patients had complete surgical resection of CNS lesions, with two having = bilateral craniotomies. In the remaining 8 patients, complete surgical = resection=20 was not possible because of tumor location, multiple parenchymal = metastases or=20 overt LM disease. Of the 21 patients, 16 received craniospinal = irradiation dose=20 21 Gy, 3 more recent patients received 18 Gy, and prior radiation = therapy=20 limited the dose in 2 patients (#2 and #8).<A name=3DTab2></A> <DIV class=3DCapt>Table 2 Clinical = history and=20 demographics of 21 patients with relapsed CNS NB treated with cRIT-based = salvage=20 regimen </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft> Pt</TH> <TH align=3Dleft> Age Dx (months)/Gender</TH> <TH align=3Dleft> MYCN, LDH</TH> <TH align=3Dleft> Sites of initial disease</TH> <TH align=3Dleft> Treatment at Dx</TH> <TH align=3Dleft> Type of relapse</TH> <TH align=3Dleft> Time to CNS relapse (months)</TH> <TH align=3Dleft> Treatment of CNS relapse</TH> <TH align=3Dleft> Dosimetry (cGy/mCi)</TH> <TH align=3Dleft> Total RIT CSF dose (cGy)</TH> <TH align=3Dleft> Disease status</TH> <TH align=3Dleft> Overall survival (months since CNS event)</TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft> 1.</TD> <TD align=3Dleft> 46, M</TD> <TD align=3Dleft> NA, 1090</TD> <TD align=3Dleft> L adr, B, BM,orbits</TD> <TD align=3Dleft> CAV =D73, P/VP =D72 thio/ABMT, S, RT, 3F8, CRA</TD> <TD align=3Dleft> 2 lesions, LM;</TD> <TD align=3Dleft> 22</TD> <TD align=3Dleft> Subtotal S, CSI 21 Gy, Irino/tmz, 131-I-3F8, = 131-I-8H9</TD> <TD align=3Dleft> 23.6=9633.8 (3F8), 20=9637 (8H9)</TD> <TD align=3Dleft> 1397</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 74</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 2.</TD> <TD align=3Dleft> 4, M</TD> <TD align=3Dleft> A, 12796</TD> <TD align=3Dleft> R. adr, pleural, liver, orbits, B, BM</TD> <TD align=3Dleft> CAV =D73, P/VP =D72 thio/ABMT, S, RT, 3F8, CRA</TD> <TD align=3Dleft> 2nd relapse, 1 right temporal lesion</TD> <TD align=3Dleft> 30</TD> <TD align=3Dleft> Subtotal S, CSI 1080 cGy, Irino/tmz, 131-I-8H9</TD> <TD align=3Dleft> 36.5=9679.5</TD> <TD align=3Dleft> 1038</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 63; MLL-associated t-AML developed 3.5 years after CNS = event=20 treated successfully</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 3.</TD> <TD align=3Dleft> 24, F</TD> <TD align=3Dleft> A</TD> <TD align=3Dleft> R RP, B, BM,</TD> <TD align=3Dleft> CAV =D73, P/VP =D72, thio/ABMT, S, RT, 3F8, CRA</TD> <TD align=3Dleft> 1 left parietal</TD> <TD align=3Dleft> 20</TD> <TD align=3Dleft> S, CSI 21 Gy, Irino/tmz, 131-I-8H9</TD> <TD align=3Dleft> 20.8=9647</TD> <TD align=3Dleft> 1423</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 53</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 4.</TD> <TD align=3Dleft> 16, M</TD> <TD align=3Dleft> A, 1132</TD> <TD align=3Dleft> R. adr, B, BM, supraclav LN</TD> <TD align=3Dleft> CAV =D73, P/VP =D72 S, RT, 3F8, CRA</TD> <TD align=3Dleft> 1 left temporal;</TD> <TD align=3Dleft> 14</TD> <TD align=3Dleft> S, CSI 21 Gy, Irino/tmz, 131-I-8H9</TD> <TD align=3Dleft> 55=9665</TD> <TD align=3Dleft> 1230</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 53</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 5.</TD> <TD align=3Dleft> 73, F</TD> <TD align=3Dleft> A, 2330</TD> <TD align=3Dleft> R. adr, L paraspinal, liver, B, BM</TD> <TD align=3Dleft> CAV =D74, P/VP =D72, S, RT, 3F8, CRA</TD> <TD align=3Dleft> 2nd relapse-BM, LM brain, spinal cord, CSF pos</TD> <TD align=3Dleft> 19</TD> <TD align=3Dleft> CSI 21 Gy, carbo, irino/tmz, 131-I-8H9</TD> <TD align=3Dleft> 43.2=9649.5</TD> <TD align=3Dleft> 2364</TD> <TD align=3Dleft> Died of infection 24 months after CNS dx; no NB at = autopsy</TD> <TD align=3Dleft> </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 6.</TD> <TD align=3Dleft> 19, F</TD> <TD align=3Dleft> A, 3165</TD> <TD align=3Dleft> R. adr, B, BM, orbits</TD> <TD align=3Dleft> CAV =D74, P/VP =D72, carbo-VP-melphalan/ABMT) S, CRA</TD> <TD align=3Dleft> 3 lesions: frontal and temporal;</TD> <TD align=3Dleft> 14</TD> <TD align=3Dleft> S (1 of 3 lesions), CSI 21 Gy, irino/tmz, = 131-I-8H9</TD> <TD align=3Dleft> 24=9638</TD> <TD align=3Dleft> 2594</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 52</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 7.</TD> <TD align=3Dleft> 23, F</TD> <TD align=3Dleft> NA, 751</TD> <TD align=3Dleft> Cervical, BM</TD> <TD align=3Dleft> PVP =D71, carbo-VP, CAV =D72, Tandem ABMT (TBI/melphalan and = cytox-carbo),=20 CRA</TD> <TD align=3Dleft> 2nd relapse; 2 lesions: cerebellar, right frontal</TD> <TD align=3Dleft> 18</TD> <TD align=3Dleft> S, CSI 21 Gy, irino/tmz, 131-I-8H9</TD> <TD align=3Dleft> 18=9635</TD> <TD align=3Dleft> 1688</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 47</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 8.</TD> <TD align=3Dleft> 48, F</TD> <TD align=3Dleft> NA</TD> <TD align=3Dleft> L adr, mediastinal, supraclavicular, BM</TD> <TD align=3Dleft> PVP x, ifos-VP =D71, CAV =D71, CV =D73, Tandem ABMT (carbo-VP, = and=20 thio-cytox), CRA</TD> <TD align=3Dleft> 1 left temporal</TD> <TD align=3Dleft> 20</TD> <TD align=3Dleft> S, CSI 1350 cGy, irino/tmz, 131-I-3F8</TD> <TD align=3Dleft> 23=9628</TD> <TD align=3Dleft> 1001</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 43</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 9.</TD> <TD align=3Dleft> 24, M</TD> <TD align=3Dleft> NA</TD> <TD align=3Dleft> R. paraspinal, B, BM</TD> <TD align=3Dleft> CAV =D73, PVP =D73, carbo-VP-melphalan/ABMT, CRA</TD> <TD align=3Dleft> 2nd relapse; 2 lesions: left frontal, right frontal</TD> <TD align=3Dleft> 35</TD> <TD align=3Dleft> S, CSI 21 Gy, irino/tmz, 131-I-8H9</TD> <TD align=3Dleft> 24=9625</TD> <TD align=3Dleft> 1857</TD> <TD align=3Dleft> BM relapse 10 months after CNS event, f/b CNS PD 14 months = later; DOD=20 35 months after CNS event</TD> <TD align=3Dleft> </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 10.</TD> <TD align=3Dleft> 29, F</TD> <TD align=3Dleft> NA, 1616</TD> <TD align=3Dleft> L adr, skull, BM</TD> <TD align=3Dleft> CAV =D73, PVP =D73, carbo-VP-melphalan/ABMT, CRA</TD> <TD align=3Dleft> Right frontal, abd disease</TD> <TD align=3Dleft> 16</TD> <TD align=3Dleft> S, CSI 21 Gy, carbo/irino/tmz, 131-I-3F8</TD> <TD align=3Dleft> 28.5</TD> <TD align=3Dleft> 1354</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 41</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 11.</TD> <TD align=3Dleft> 56, M</TD> <TD align=3Dleft> NA, 1712</TD> <TD align=3Dleft> R. adr, BM, B</TD> <TD align=3Dleft> 5 cycles high dose chemo, MIBG/ABMT, cyclo/topo, 3F8, CTV =D72, = CRA</TD> <TD align=3Dleft> Right frontal, + Bony lesion</TD> <TD align=3Dleft> 37</TD> <TD align=3Dleft> S, CSI 21 Gy, irino, irino/tmz, 131-I-3F8</TD> <TD align=3Dleft> 23.5</TD> <TD align=3Dleft> 823</TD> <TD align=3Dleft> Relapse in rib lesion at time of CNS event being treated; = AWD</TD> <TD align=3Dleft> 33</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 12.</TD> <TD align=3Dleft> 37, M</TD> <TD align=3Dleft> NA, 1161</TD> <TD align=3Dleft> L adr, B, BM</TD> <TD align=3Dleft> carbo-P/V-C/VP/V, MIBG/ABMT, 3F8, CRA</TD> <TD align=3Dleft> 2 lesions: Left and right temporal</TD> <TD align=3Dleft> 21</TD> <TD align=3Dleft> S (1 of 2 lesions), CSI 21 Gy, irino, Irino/tmz,=20 carbo/irino/tmz/cyt/VP, 131-I-8H9</TD> <TD align=3Dleft> 27.1</TD> <TD align=3Dleft> 1471</TD> <TD align=3Dleft> Relapse in BM 9 months after CNS event; DOD 30 months after CNS = event</TD> <TD align=3Dleft> </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 13.</TD> <TD align=3Dleft> 36, M</TD> <TD align=3Dleft> A</TD> <TD align=3Dleft> L adr, B, BM</TD> <TD align=3Dleft> CAV =D73, PVP =D73, carbo-VP-melphalan/ABMT, CRA</TD> <TD align=3Dleft> Right frontal</TD> <TD align=3Dleft> 32</TD> <TD align=3Dleft> S, CSI 21 Gy, irino/tmz, 131-I-8H9</TD> <TD align=3Dleft> 71.5</TD> <TD align=3Dleft> 3309</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 28</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 14.</TD> <TD align=3Dleft> 38, M</TD> <TD align=3Dleft> A, 2700</TD> <TD align=3Dleft> R. adr, B, BM</TD> <TD align=3Dleft> Cyclo/topo, CAV =D72, PVP =D71, carbo-VP-melphalan-MIBG/ABMT, = Hu 14.18-IL2,=20 irino/tmz =D72</TD> <TD align=3Dleft> 2 lesions: Right temporal and tectal; refractory systemic = NB</TD> <TD align=3Dleft> 19</TD> <TD align=3Dleft> S (1 of 2 lesions), CSI 21 Gy, irino, irino/tmz/carbo,=20 131-I-8H9</TD> <TD align=3Dleft> 35=9644</TD> <TD align=3Dleft> 2135</TD> <TD align=3Dleft> Persistent bone and BM NB; DOD 15 months after CNS = event</TD> <TD align=3Dleft> </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 15.</TD> <TD align=3Dleft> 9, M</TD> <TD align=3Dleft> NA, 1336</TD> <TD align=3Dleft> L adr, testes, penis, BM</TD> <TD align=3Dleft> Observed=97had spontaneous regression until St 4 NB age 2.5 = years, then=20 treated with CAV =D73, PVP =D72, 3F8</TD> <TD align=3Dleft> 2nd relapse, 6 parenchymal masses</TD> <TD align=3Dleft> 35</TD> <TD align=3Dleft> CSI 21 Gy, irino, irino-tmz, 131-I-8H9</TD> <TD align=3Dleft> 147</TD> <TD align=3Dleft> 8820</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 20</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 16.</TD> <TD align=3Dleft> 30, F</TD> <TD align=3Dleft> NA</TD> <TD align=3Dleft> R. adr, liver, BM</TD> <TD align=3Dleft> CAV =D73, PVP =D72, CTV =D72, 3F8</TD> <TD align=3Dleft> L middle cranial fossa with herniation</TD> <TD align=3Dleft> 9</TD> <TD align=3Dleft> S, CSI 21 Gy, irino, irino-tmz, 131-I-8H9</TD> <TD align=3Dleft> 17.2</TD> <TD align=3Dleft> 1788</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 14</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 17.</TD> <TD align=3Dleft> 18, F</TD> <TD align=3Dleft> A</TD> <TD align=3Dleft> R. adr, thoracic, lumbar and sacral masses, right mandible, = BM</TD> <TD align=3Dleft> carbo-P/V-C/VP/V =D78 cycles, CTV =D72, 3F8</TD> <TD align=3Dleft> Cerebellar mass</TD> <TD align=3Dleft> 11</TD> <TD align=3Dleft> S, CSI 21 Gy, irino, irino-tmz, 131-I-8H9</TD> <TD align=3Dleft> 23.8</TD> <TD align=3Dleft> 2384</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 12</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 18.</TD> <TD align=3Dleft> 19, M</TD> <TD align=3Dleft> A</TD> <TD align=3Dleft> L supraclavicular node, BM, cortical = bone, malignant=20 pleural effusion</TD> <TD align=3Dleft> Cyclo/topo x2, Cisplatin/Etoposide x2, CAV x2,=20 ABMT, RT, 3F8</TD> <TD align=3Dleft> R LM cerebellopontine angle </TD> <TD align=3Dleft> 10</TD> <TD align=3Dleft> Subtotal resection, Irino-tmz x2, CSI 21 Gy,=20 131-I-8H9</TD> <TD align=3Dleft> *</TD> <TD align=3Dleft> *</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 10</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 19.</TD> <TD align=3Dleft> 5, F</TD> <TD align=3Dleft> A</TD> <TD align=3Dleft> R. adr, R rib lesion </TD> <TD align=3Dleft> Carbo/Etoposide, CAV x3, = Cisplatin/Etoposide x2, S,=20 ABMT</TD> <TD align=3Dleft> cerebellar mass</TD> <TD align=3Dleft> 18</TD> <TD align=3Dleft> S, CSI 18 Gy, Irinotmz, 131-I-8H9</TD> <TD align=3Dleft> *</TD> <TD align=3Dleft> *</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 10</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 20.</TD> <TD align=3Dleft> 40, M</TD> <TD align=3Dleft> NA</TD> <TD align=3Dleft> L adr, B, BM</TD> <TD align=3Dleft> PVPx2, CAV x3, ifos/VP, irino-carbotmz, S,=20 RT, 3F8/Glucan, CRA</TD> <TD align=3Dleft> L anterolateral frontal lobe</TD> <TD align=3Dleft> 19</TD> <TD align=3Dleft> S, CSI 18 Gy, Irinotmz, 131-I-8H9</TD> <TD align=3Dleft> *</TD> <TD align=3Dleft> *</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 9</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 21.</TD> <TD align=3Dleft> 22, F</TD> <TD align=3Dleft> A</TD> <TD align=3Dleft> L adr, B </TD> <TD align=3Dleft> carbo-P/V-C/VP/V, S, CTV, RT, 3F8, CRA</TD> <TD align=3Dleft> R superior temporal gyrus</TD> <TD align=3Dleft> 31</TD> <TD align=3Dleft> S, CSI 18 Gy, Irino, Irino-tmz, 131-I-8H9</TD> <TD align=3Dleft> *</TD> <TD align=3Dleft> *</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 7</TD></TR></TBODY></TABLE> <DIV class=3DCapt> <DIV class=3DCaptCont> <DIV>3F8 anti-GD2 monoclonal antibody 3F8 treatment,=20 8H9 monoclonal antibody 3F8 treatment, adr adrenal, = ABMT=20 myeloablative treatment with autologous bone marrow rescue, A = amplified,=20 AWD alive with disease, BM bone marrow, b bones, = CAV=20 cyclophosphamide-doxorubicin-vincristine, carbo carboplatin, = CR=20 complete remission, CRA cis-retinoic acid, CSF=20 cerebrospinal fluid, CSI 2100 cGy radiation therapy, = Dx=20 diagnosis, F female, irino irinotecan, LDH serum = lactic=20 dehydrogenase (U/L), LM leptomeningeal, LN = lymphadenopathy,=20 M male, MYCN N-myc amplification status, NB = not-amplified,=20 NB neuroblastoma, P/VP cisplatin-etoposide, R = right, RT,=20 S surgical resection on bulky disease, t-AML = treatment-related acute=20 myelogenous leukemia, thio thiotepa-carboplatin, tmz = temozolomide,=20 VP etoposide </DIV></DIV> <DIV class=3DCaptCont> <DIV>*Not yet calculated </DIV></DIV></DIV><A = name=3DTab3></A> <DIV class=3DCapt>Table 3 Overall = summary of=20 21 patients treated with cRIT-based CNS treatment plan since 2003 </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dleft></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft> Characteristics</TH> <TH align=3Dleft> N </TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft> Median age at initial diagnosis (months)</TD> <TD align=3Dleft> 29.3</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Median time to detection of CNS disease (months) from initial=20 diagnosis</TD> <TD align=3Dleft> 21.4</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Prior treatment with myeloablative chemotherapies</TD> <TD align=3Dleft> 13</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Isolated CNS disease as first relapse</TD> <TD align=3Dleft> 16</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Isolated CNS disease as second relapse</TD> <TD align=3Dleft> 3</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> CNS and systemic NB</TD> <TD align=3Dleft> 2</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> LM</TD> <TD align=3Dleft> 2</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Single parenchymal lesion</TD> <TD align=3Dleft> 11</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Multiple parenchymal lesions</TD> <TD align=3Dleft> 7</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Both LM and parenchymal</TD> <TD align=3Dleft> 2</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> CSF cytology positive</TD> <TD align=3Dleft> 1</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Gross total surgical resection</TD> <TD align=3Dleft> 13</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Treated with 21 Gy craniospinal irradiation</TD> <TD align=3Dleft> 16</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Number patients alive</TD> <TD align=3Dleft> 17</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Number in CR</TD> <TD align=3Dleft> 16 (7-74 months)</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Death from isolated CNS NB</TD> <TD align=3Dleft> 0</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Death from systemic NB</TD> <TD align=3Dleft> 2</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Death from CNS and systemic NB</TD> <TD align=3Dleft> 1</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Median time to death from CNS detection (months) (4 = patients)</TD> <TD align=3Dleft> 26.5</TD></TR></TBODY></TABLE></DIV></DIV> <DIV><A name=3DSec7></A> <DIV class=3DHeading3>Toxicity</DIV> Craniospinal irradiation was associated with transient and = self-limited=20 somnolence syndrome. Manageable acute toxicities from chemotherapy = included=20 self-limited diarrhea following irinotecan and myelosuppression = requiring stem=20 cell support after chemotherapy in five patients. Following cRIT = injections,=20 self-limited fever, nausea and headache were seen after = 131I-3F8, or=20 after 131I-8H9 administration, transient grade 1 creatinine=20 elevation, and grade 1 and 3 transient elevated serum transaminase. No=20 significant myelosuppression was seen following cRIT injections of=20 131I-3F8 or 131I-8H9 injections at dose levels=20 10=9630 mCi. Self-limited myelosuppression was observed for=20 131I-8H9 injections ≥40 mCi. Two years after cRIT, one patient developed idiopathic = thrombocytopenic=20 purpura which resolved by 6 months. Five patients remain on oral = thyroid=20 hormone replacement for biochemical hypothyroidism attributed to = treatment.=20 Supplemental growth hormone administration for short stature has been=20 administered to one patient. Cataract removal was performed in one = patient=20 2 years after detection of CNS disease. In another patient, = MLL-associated=20 secondary leukemia emerged 3 years after cRIT, 4 years after = dura=20 relapse and 7 years from the initial NB diagnosis; successful = treatment=20 with an allogeneic bone marrow transplant followed. Among the seven patients tested with formal neurocognitive = evaluations, no=20 unexpected deficits were noted. Seventeen children attending primary = school are=20 mainstreamed in regular classes, although two patients are receiving = additional=20 early intervention services (patients #3 and 7). </DIV> <DIV><A name=3DSec8></A> <DIV class=3DHeading3>Survival</DIV> <DIV class=3DPara> <DIV>Out of 21 patients, 17 remain alive 7=9674 months (median 33) = months from the=20 time of CNS NB diagnosis (Fig. <A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#Fig2">2</A>),=20 all with no evidence of CNS disease. The longest survivor (patient #1), = having=20 had refractory bone marrow NB after myeloablative chemotherapy and then = LM=20 spread, is now 6.5 years in continuous CNS and systemic complete = remission=20 (Fig. <A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#Fig3">3</A>).=20 Three deaths occurred from non-CNS events. One patient (# 5) died of = pulmonary=20 infection 23 months after the detection of LM NB that had initially = progressed following craniospinal irradiation; she achieved a = long-standing=20 remission of disease with resolution of NB on spine MR and CSF cytology=20 following 131I-8H9; no NB in the CNS or otherwise was = detected at=20 autopsy. One patient (# 14) died of refractory lung and bone marrow NB=20 15 months after the CNS event, and another died of progressive bone = marrow=20 disease 30 months after the CNS event. Only one patient (# 9) progressed = in the=20 CNS, 14 months after the initial CNS event and 2 months after = his=20 third marrow relapse. He died of both progressive CNS and systemic = disease 35=20 months after the CNS event. As extended survival was observed in = patients=20 treated with both 131I-3F8 and escalating doses of=20 131I-8H9 on the phase I study, there was no clear therapeutic = response favoring one cRIT mAb over the other.=20 <DIV class=3DFigure><A name=3DFig2></A><IMG=20 alt=3DMediaObjects/11060_2009_38_Fig2_HTML.gif=20 src=3D"http://www.springerlink.com/content/p07804022q60v008/MediaObjects/= 11060_2009_38_Fig2_HTML.gif"></DIV> <DIV class=3DCapt>Fig. 2 Kaplan=96Meier curve=20 demonstrating overall survival in months from CNS disease detection for = 21=20 patients treated with current cRIT-based treatment plan; 17 patients are = alive=20 </DIV> <HR> <DIV class=3DFigure><A name=3DFig3></A><IMG=20 alt=3DMediaObjects/11060_2009_38_Fig3_HTML.jpg=20 src=3D"http://www.springerlink.com/content/p07804022q60v008/MediaObjects/= 11060_2009_38_Fig3_HTML.jpg"></DIV> <DIV class=3DCapt>Fig. 3 A = Relapsed=20 metastatic NB in a patient who remains progression-free, now 74+ months = since=20 detection of CNS disease B. This patient had leptomeningeal = disease and a=20 subtotal resection, followed by craniospinal irradiation and cRIT </DIV> <HR> </DIV></DIV></DIV></DIV> <DIV><A name=3DSec9></A> <HR> <DIV class=3Dheading2>Discussion</DIV> Metastatic NB remains one of the most difficult malignancies to cure. = The CNS=20 is a sanctuary site for NB. Current treatments for CNS relapses are = inadequate,=20 carrying a high morbidity and mortality rate. Few advances have affected = the=20 clinical outcome for such patients. Upfront treatment strategies = including=20 thiotepa-based myeloablative regimens for newly-diagnosed patients do = not=20 adequately treat the CNS [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR22">22</A></CITE>].=20 Novel agents that may detect and treat microscopic disease may improve = patient=20 survival. We reviewed 21 patients treated at MSKCC since 2003 for = relapsed NB=20 involving the CNS treated uniformly with an approach aimed at = eradicating bulky=20 and microscopic residual disease in the CNS, as well as minimal residual = systemic disease that may herald further relapses. Neurosurgical = intervention=20 served to decrease edema, control hemorrhage, and remove bulky tumor = prior to=20 starting radiation therapy. Although craniospinal irradiation required = daily=20 anesthesia for this very young patient population, this treatment was = well=20 tolerated in the outpatient setting, even with concurrent irinotecan. = Stem cell=20 rescue was necessary for those patients in whom bone marrow reserve was = marginal=20 at the time of CNS relapse. This is the first time intrathecal radiolabeled MoAbs have been = incorporated=20 into curative treatment strategies for patients with CNS NB. At the = current=20 doses, intraventricular administration of 131I-3F8 or=20 131I-8H9 is associated with manageable, acute side effects = including=20 transient headache, nausea, fever, and vomiting. We have established = that a=20 tumoricidal dose to the CSF can be delivered by a single injection, with = levels=20 to the blood and bone marrow below clinical toxicity. For a GD2-positive = free=20 floating tumor cell suspension, as in the case of LM disease, the = enhancement in=20 dose to the cells binding 3F8 can be as great as 77% [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR23">23</A></CITE>].=20 If one extrapolates the radiation dose to tumor cells based on their=20 preferential binding (>10:1) to these MoAbs, a substantial = therapeutic window=20 between effective tumor cell ablation and the dose received to normal = brain and=20 blood could be achieved. The extended survival of this patient population is encouraging given = the=20 rapidly fatal nature of CNS relapse=97no survivors among 11 patients, = median time=20 to death of 6.6 months=97in our previously published experience = before=20 initiation of the current treatment program [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR2">2</A></CITE>].=20 This poor survival among patients with CNS NB has been noted in other = large=20 series. Among 23 patients with recurrent metastatic CNS NB reviewed by = Matthay=20 et al. [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR3">3</A></CITE>]=20 despite treatment, 20 patients died <9.8 months and 22 of 23 by=20 13 months after the time of CNS disease detection. Shortened = survival was=20 most notable for patients with LM disease, 0.9=966 months [<CITE><A = href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR3">3</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR23">23</A></CITE>].=20 We recognize that this cohort of patients is limited by selection in = that=20 even in the cRIT-era, rapid deterioration and death may occur in some = patients=20 within days or weeks, usually from widespread refractory systemic or LM = disease,=20 precluding treatment initiation or completion. In contrast to patients = whose CNS=20 disease occurs in the setting of rapidly progressing systemic NB, CNS = disease as=20 an isolated relapse appears to be readily controllable and possibly = curable with=20 the proposed regimen, even when multiple parenchymal nodules at the time = of=20 relapse are detected. It is difficult to ascertain the impact of any individual treatment = modality=20 in this encouraging salvage regimen. Surgical debulking of parenchymal = masses=20 was possible in 62% of patients. Temozolomide-irinotecan chemotherapy = was=20 primarily used to control systemic NB, as previously reported [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR14">14</A></CITE>],=20 but is advantageous in this setting because of penetrance across the=20 blood=96brain-barrier. The integral role of craniospinal irradiation is also acknowledged. = However,=20 while it likely aids in disease control, external beam radiotherapy to = the=20 craniospinal axis and to sites of resected or unresected visible disease = has=20 been part of unsuccessful treatment programs previously reported = [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR2">2</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR3">3</A></CITE>].=20 Because of the young patient age and success of 2100 cGy for = microscopic=20 residual disease for the primary site [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR24">24</A></CITE>],=20 no patient received 2340 cGy or 3600 cGy craniospinal = irradiation, the=20 dose typically administered to patients with medulloblastoma in attempt = to=20 sterilize the thecal space. Indeed, among our 17 survivors after = cRIT-salvage, 5=20 were treated with a lower dose of radiation, 2 because of prior relapses = and=20 radiation exposure (1080 cGy and 1350 cGy), and 3 at 1800 cGy. = One=20 patient had progressive nodular enhancement of spinal cord leptomeninges = post=20 radiation (2160 cGy). Treatment response was noted after serial = injections=20 of 131I-8H9 therapy. As the target cGy delivered by cRIT is=20 increased, we believe it is safe to reduce the dose delivered by = conventional=20 external beam radiation therapy, and are now delivering 1800 cGy to = current=20 patients. We also note the encouraging preclinical data demonstrating = the=20 enhanced therapeutic effect of combination external beam radiation = therapy and=20 cRIT, compared to that observed with either therapy alone [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR25">25</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR26">26</A></CITE>].=20 This combination of reduced-dose craniospinal irradiation aimed at = controlling=20 bulk parenchymal and nodular LM disease and cRIT targeting micrometastic = NB, may=20 well be contributing to the prolonged survival seen in our patient = cohort. Several questions require focused study in the immediate future. What = is the=20 lower limit of craniospinal irradiation that can be administered with = cRIT? What=20 is the minimal total dose CSF cGy delivered by cRIT that still achieves=20 sterilization of the thecal space? Is there an advantage of 3F8, whose = acute and=20 long term toxicity have been well characterized, over 8H9? If the = external beam=20 dose of craniospinal irradiation is reduced, in all likelihood, cRIT = with 8H9=20 would be more advantageous than 3F8 given its higher mCi/injection.=20 Alternatively, cRIT with 3F8 is not associated with myelosuppression in = patients=20 with poor bone marrow reserve. The use of alternative isotopes, such as=20 alpha-emitting 225Ac-8H9 under preclinical investigation, may = further=20 improve the efficacy of cRIT with MoAbs. As 124I-8H9 PET/CT = provides=20 higher resolution and contrast images than SPECT with = 131I-8H9 for=20 distribution, targeting and dosimetry, 124I-8H9/PET appears = to be a=20 promising tool that may aid in the treatment planning for = radioimmunotherapy=20 trials for CNS malignancies. This may allow for patient-specific = dosimetry on=20 future phase II studies, where a specific total CSF cGy is desirable = [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR27">27</A></CITE>].=20 Our results support the importance of timely administration of = multi-modality=20 therapy including surgery and sterilization of the craniospinal axis = with=20 combined external beam radiotherapy and cRIT with 131I-3F8 or = 131I-8H9. Eliminating the sanctuary site for NB in the CNS = has=20 resulted in both long-term local=96regional and systemic disease = control. We demonstrate that a multi-modality treatment program centered on=20 radiolabeled MoAb to target radiation to CNS tumors using CSF as a = conduit=20 appears to improve the survival of patients with relapsed CNS NB, even = in the=20 presence of overt LM disease. The modest and manageable side effects of = the cRIT=20 are also noteworthy. CNS prophylaxis may be possible if the NB patient=20 population at high risk for CNS relapse can be identified at the time of = diagnosis. Such a combined multi-modality approach to improve survival = may be=20 applicable to other solid tumors metastasizing to the CNS. </DIV> <DIV class=3DAcknowledgments><SPAN=20 class=3DAcknowledgmentsHeading>Acknowledgments We= wish to=20 thank the Cyclotron-Radiochemistry Core of MSKCC and Yiauchung Sheh for=20 production and supply of the I-124. This study was supported in part by = the=20 FDA-KK-01A2, CA89935, CA89936, CA106450, CA117076, FD003089, PO1 = CA033049,=20 Robert Steel Foundation, Katie=92s Find A Cure Fund, Pediatric Cancer = Foundation,=20 Aubrey Fund, Hope Street Kids, Major Fund, Leptomeningeal Research Fund, = the=20 MSKCC Experimental Therapeutics Center and the Ludwig Center for Cancer=20 Immunotherapy.</DIV> <HR> <H2><A name=3DBib1></A>References </H2> <TABLE> <TBODY class=3DCitation> <TR vAlign=3Dtop> <TD>1.</TD> <TD><A name=3DCR1></A>Choi HS, Koh SH, Park ES, Shin HY, Ahn HS = (2005) CNS=20 recurrence following CD34+ peripheral blood stem cell = transplantation in=20 stage 4 neuroblastoma. 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From: Subject: 10.1007/s11060-009-0038-7 Date: Sun, 15 Nov 2009 15:55:33 +0100 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0116_01CA660C.103AA540" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.5579 This is a multi-part message in MIME format. ------=_NextPart_000_0116_01CA660C.103AA540 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.springerlink.com/content/p07804022q60v008/fulltext.html 10.1007/s11060-009-0038-7</TIT= LE> <META content=3D"text/html; charset=3DISO-8859-1" = http-equiv=3DContent-Type><LINK=20 rel=3DstyleSheet type=3Dtext/css=20 href=3D"http://www.springerlink.com/config/css/A++_common.css"><LINK=20 rel=3DstyleSheet type=3Dtext/css=20 href=3D"http://www.springerlink.com/config/css/content_A++_SpringerLink.c= ss"> <META name=3DGENERATOR content=3D"MSHTML 8.00.6001.18852"></HEAD> <BODY class=3Dfor-print> <TABLE border=3D1 cellPadding=3D2> <TBODY> <TR class=3Dheader> <TD>Journal of Neuro-Oncology</TD></TR> <TR> <TD>=A9 Springer Science+Business Media, = LLC. 2009</TD></TR> <TR> <TD>10.1007/s11060-009-0038-7</TD></TR></TBODY></TABLE> <H2 class=3Drubric>Clinical Study - Patient Study</H2> <DIV class=3DHeading1><A name=3Dtitle></A>Compartmental intrathecal=20 radioimmunotherapy: results for treatment for metastatic CNS = neuroblastoma=20 </DIV> Kim Kramer1 <A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#ContactOfAuthor1"><IMG=20 border=3D0 alt=3D"Contact Information"=20 src=3D"http://www.springerlink.com/content/p07804022q60v008/contact.gif">= </A>,=20 Brian H. Kushner1, Shakeel Modak1,=20 Neeta Pandit-Taskar2, = Peter Smith-Jones2,=20 Pat Zanzonico3, John L. Humm3,=20 Hong Xu1, Suzanne L. Wolden4,=20 Mark M. Souweidane5, = Steven M. Larson2=20 and Nai-Kong V. Cheung1 <TABLE> <TBODY> <TR vAlign=3Dtop> <TD><A = name=3DAff1></A>(1) </TD> <TD>Department of Pediatrics, Memorial=20 Sloan-Kettering Cancer Center, 1275 York Avenue, Box 429, New = York,=20 NY 10065, USA</TD></TR></TBODY></TABLE> <TABLE> <TBODY> <TR vAlign=3Dtop> <TD><A = name=3DAff2></A>(2) </TD> <TD>Department of Nuclear Medicine, = Memorial=20 Sloan-Kettering Cancer Center, New York, NY 10065,=20 USA</TD></TR></TBODY></TABLE> <TABLE> <TBODY> <TR vAlign=3Dtop> <TD><A = name=3DAff3></A>(3) </TD> <TD>Department of Medical Physics, = Memorial=20 Sloan-Kettering Cancer Center, New York, NY 10065,=20 USA</TD></TR></TBODY></TABLE> <TABLE> <TBODY> <TR vAlign=3Dtop> <TD><A = name=3DAff4></A>(4) </TD> <TD>Department of Radiation Oncology, = Memorial=20 Sloan-Kettering Cancer Center, New York, NY 10065,=20 USA</TD></TR></TBODY></TABLE> <TABLE> <TBODY> <TR vAlign=3Dtop> <TD><A = name=3DAff5></A>(5) </TD> <TD>Department of Neurosurgery, Memorial=20 Sloan-Kettering Cancer Center, New York, NY 10065,=20 USA</TD></TR></TBODY></TABLE> <A name=3DContactOfAuthor1></A> <TABLE class=3DContact> <TBODY> <TR> <TD vAlign=3Dtop><IMG border=3D0 alt=3D"Contact Information"=20 = src=3D"http://www.springerlink.com/content/p07804022q60v008/contact.gif">= </TD> = <TD>Kim Kramer<BR= >Email:=20 <A=20 = href=3D"mailto:Kramerk@mskcc.org">Kramerk@mskcc.org</A></TD></TR></TBODY>= </TABLE> Received:=20 3 June 2009 Accepted:=20 12 October 2009 Published online:=20 5 November 2009 <DIV class=3DAbstract><A name=3DAbs1></A><SPAN=20 class=3DAbstractHeading>Abstract Innovation in the = management of=20 brain metastases is needed. We evaluated the addition of compartmental=20 intrathecal antibody-based radioimmunotherapy (cRIT) in patients with = recurrent=20 metastatic central nervous system (CNS) neuroblastoma following surgery, = craniospinal irradiation, and chemotherapy. Twenty one patients treated = for=20 recurrent neuroblastoma metastatic to the CNS, received a = cRIT-containing=20 salvage regimen incorporating intrathecal 131I-monoclonal = antibodies=20 (MoAbs) targeting GD2 or B7H3 following surgery and radiation. Most = patients=20 also received outpatient craniospinal irradiation, 3F8/GMCSF = immunotherapy,=20 13-cis-retinoic acid and oral temozolomide for systemic control.=20 Seventeen of 21 cRIT-salvage patients are alive 7=9674 months = (median 33=20 months) since CNS relapse, with all 17 remaining free of CNS = neuroblastoma. One=20 patient died of infection at 22 months with no evidence of disease = at=20 autopsy, and one of lung and bone marrow metastases at 15 months, = and one=20 of progressive bone marrow disease at 30 months. The cRIT-salvage = regimen was=20 well tolerated, notable for myelosuppression minimized by stem cell = support=20 (n =3D 5), and biochemical hypothyroidism=20 (n =3D 5). One patient with a 7-year history of = metastatic=20 neuroblastoma is in remission from MLL-associated secondary leukemia. = This is=20 significantly improved to published results with non-cRIT based where = relapsed=20 CNS NB has a median time to death of approximately 6 months. The=20 cRIT-salvage regimen for CNS metastases was well tolerated by young = patients,=20 despite their prior history of intensive cytotoxic therapies. It has the = potential to increase survival with better than expected quality of = life. </DIV> <SPAN=20 class=3DKeywordHeading>Keywords Neuroblastoma -&nb= sp;Radioimmunotherapy - CNS=20 metastases - Intrathecal <DIV class=3DFulltext> <DIV><A name=3DSec1></A> <HR> <DIV class=3Dheading2>Introduction</DIV> Neuroblastoma (NB) is the most common extracranial solid tumor in = children.=20 Recurrent metastatic NB is difficult to cure, particularly in patients = with=20 central nervous system (CNS) disease [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR1">1</A></CITE>].=20 The CNS has emerged as a sanctuary site leading to relapse. Among large = series,=20 the incidence of leptomeningeal (LM) or CNS parenchymal disease in = relapsed=20 patients is 6=968% [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR2">2</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR3">3</A></CITE>].=20 CNS relapses have been almost always fatal [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR1">1</A></CITE>=96<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR3">3</A></CITE>]=97hence=20 the need for innovative treatments. Compartmental radioimmunotherapy = (cRIT)=20 using radioiodinated monoclonal antibodies (MoAbs) administered = intrathecally=20 results in a favorable cerebrospinal fluid (CSF) to blood activity=20 concentrations and radiation dose ratios and may be useful in the = treatment of=20 LM disease [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR4">4</A></CITE>=96<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR6">6</A></CITE>].=20 For example, cRIT using 131I-labeled murine anti-tenascin = MoAbs in=20 patients with malignant glioma was feasible, well tolerated and improved = survival [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR7">7</A></CITE>=96<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR9">9</A></CITE>].=20 A phase I study at Memorial Sloan-Kettering Cancer Center (MSKCC)=20 demonstrated the feasibility of cRIT for patients with GD2-expressing LM = neoplasms using the anti-GD2 murine MoAb 3F8 labeled with = 131I=20 [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR10">10</A></CITE>].=20 Another murine MoAb, 8H9, is specific for 4Ig-B7H3, a 58 kD surface=20 immunomodulatory glycoprotein that inhibits natural killer cells and T = cells.=20 The B7-H3 protein is distributed on the cell membrane of a broad = spectrum of=20 pediatric and adult solid tumors, preferentially expressed on tumors as = compared=20 to normal human tissues [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR11">11</A></CITE>].=20 When radiolabeled with 131I, 8H9 can deliver therapeutic = doses of=20 radiation to solid tumors and suppress tumor cell growth in established=20 xenografts [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR12">12</A></CITE>].=20 We now report the survival of patients with relapsed CNS NB treated with = a=20 cRIT-based salvage regimen targeting minimal residual disease. = </DIV> <DIV><A name=3DSec2></A> <HR> <DIV class=3Dheading2>Methods</DIV> Staging was carried out according to the International Neuroblastoma = Staging=20 System [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR13">13</A></CITE>].=20 CNS NB was defined as LM disease or metastatic deposits in the CNS = parenchyma=20 excluding skull bone-based metastases. The disease was confirmed = pathologically=20 in 20 patients, and radiographically in 1 patient with numerous = enhancing=20 masses. <DIV><A name=3DSec3></A> <DIV class=3DHeading3>Overall treatment plan</DIV> <DIV class=3DPara> <DIV>The overall salvage regimen in 17 patients from July 2003 through = March=20 2009 is summarized in Table <A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#Tab1">1</A>.=20 Parenchymal CNS disease was immediately resected when possible, with = concurrent=20 placement of an intraventricular Ommaya catheter to deliver intrathecal = therapy.=20 Craniospinal irradiation (1080=962160 cGy) was delivered in twice = daily=20 fractions over a 3 week period, with a boost to parenchymal masses = (up to=20 3000 cGy total) when possible. Craniospinal irradiation was = delivered in=20 the outpatient setting in conjunction with a course of irinotecan = followed by a=20 course of irinotecan-temozolomide =B1 carboplatin [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR14">14</A></CITE>].=20 The resulting myelosuppression was reversed by infusion of previously = collected=20 peripheral blood stem cells when necessary. Consolidation with cRIT then = began=20 (see below). After completing the cRIT protocol, outpatient maintenance = systemic=20 therapy consisted of immunotherapy using intravenous 3F8 plus=20 granulocyte=96macrophage colony-stimulating factor (GM-CSF) as = previously=20 described [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR15">15</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR16">16</A></CITE>],=20 oral 13-cis-retinoic acid [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR17">17</A></CITE>],=20 and oral temozolomide [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR18">18</A></CITE>].=20 This study was approved by MSKCC IRB, and informed written consents for = all=20 treatments were obtained from guardians prior to treatment after they = understood=20 the potential side-effects of each agent and the possibility of = unforeseen=20 toxicities.<A name=3DTab1></A> <DIV class=3DCapt>Table 1 General = cRIT-based=20 treatment plan for patients with relapsed CNS NB </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dleft></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft> Time</TH> <TH align=3Dleft> Intervention</TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft> Day 0</TD> <TD align=3Dleft> Resection of CNS disease when possible; Ommaya catheter=20 placement</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Day 7</TD> <TD align=3Dleft> Irinotecan 50 mg/m2/dose IV daily =D75 = </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Day 14</TD> <TD align=3Dleft> Craniospinal irradiation 1080=962160 cGy/boost=20 2560=963000 cGy</TD></TR> <TR class=3Dnoclass> <TD rowSpan=3D4 align=3Dleft> Week 7</TD> <TD align=3Dleft> Irinotecan 50 mg/m2/dose IV daily =D75 = </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Temozolamide 250 mg/m2/dose daily =D75 = </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Carboplatin 500 mg/m2/dose daily =D72 (only if = systemic=20 NB present) </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Stem cell rescuea </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Week 14</TD> <TD align=3Dleft> Serial injections of intra-Ommaya 131I-MoAbs = </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Week 30</TD> <TD align=3Dleft> GMCSF/IV 3F8 every 3=964 weeks (4 cycles)</TD></TR> <TR class=3Dnoclass> <TD rowSpan=3D2 align=3Dleft> Weeks 40=96104</TD> <TD align=3Dleft> Oral cis-retinoic acid=20 160 mg/m2 day =D7 14 days (6 = cycles)=20 alternating with </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Oral temozolomide = 75 mg/m2/day =D7 42 days=20 (5 cycles) </TD></TR></TBODY></TABLE> <DIV class=3DCapt> <DIV class=3DCaptCont> <DIV>3F8=97monoclonal anti-GD2 antibody</DIV></DIV> <DIV class=3DCaptCont> <DIV>aIf needed; MoAbs monoclonal antibodies, = GMCSF=20 granulocyte macrophage colony stimulating factor=20 </DIV></DIV></DIV></DIV></DIV></DIV> <DIV><A name=3DSec4></A> <DIV class=3DHeading3>cRIT treatment</DIV> Patients were enrolled into a protocol testing cRIT, = 131I-3F8=20 (n =3D 3, NCT00445965), or 131I-8H9=20 (n =3D 11, NCT00089245) for individuals with high-risk = metastatic=20 CNS tumors. The decision to use 3F8 or 8H9 was dependent on protocol=20 opening/timing (intrathecal 131I-3F8 was the first available=20 antibody) and systemic disease status (intrathecal 131I-3F8 = allowed=20 for two cycles of systemic chemotherapy between injections). Homogenous=20 reactivity to 3F8 [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR19">19</A></CITE>]=20 and 8H9 [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR11">11</A></CITE>]=20 on neuroblastoma tumors has previously been demonstrated and was not = required at=20 study entry. Eligible patients had no rapidly deteriorating neurologic=20 examination or obstructive hydrocephalus, had an absolute neutrophil = count=20 >1000/=B5l, platelet count >50,000/=B5l, blood urea nitrogen=20 <30 mg/dl, serum bilirubin <3.0 mg/dl, and serum = creatinine=20 <2 mg/dl. Ommaya catheter position, patency and CSF flow were = evaluated=20 by pre-treatment 111-Indium diethylene triamine pentaacetic acid (DTPA) = studies.=20 Patients had baseline magnetic resonance imaging (MRI) studies of the = brain and=20 spinal cord and CSF cytology examination approximately 1 month = prior to and=20 after cRIT. MoAbs 3F8 and 8H9 were purified and radiolabeled at MSKCC using = iodogen=20 [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR20">20</A></CITE>]=20 according to specifications detailed in the respective investigational = new drug=20 applications, averaging 5 mCi/mg 3F8 or 8H9. Patients received an = oral=20 saturated solution of potassium iodide and liothyronine to suppress = thyroid=20 function and were premedicated with acetaminophen, lorazepam and=20 diphenhydramine. Intra-Ommaya treatment comprised: (a) an injection of = 131I-3F8=20 (10 mCi) every 2=963 weeks for a total of four injections = (total dose=20 40 mCi) based on the MTD established on a phase I study [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR10">10</A></CITE>]=20 or (b) 1 or 2 monthly injections 131I-8H9 = (10=9660 mCi/injection).=20 Dosing was based on the treatment plan on the phase II study (3F8) or = the phase=20 I dose escalation level (8H9) at the time of patient entry. Dose = adjustments=20 based on CSF volume were made for patients less than 3 years of age = (<12 months, 50% dose reduction; 13=9636 months, 33% dose = reduction;=20 >36 months, full dose). Clinical status, vital signs and = neurologic=20 examination were monitored overnight. Repeat injections were = administered in the=20 absence of grade 3 or 4 toxicity using the National Cancer Institute = Common=20 Toxicity Criteria [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR21">21</A></CITE>].=20 Upon completion of the cRIT protocol, CNS and systemic disease status = was=20 assessed approximately every 3 months by CT of the primary site, = MRI brain=20 and spine, 123I-meta-iodobenzylguanidine (MIBG) scans, = multiple bone=20 marrow aspirations and biopsies, CSF cytology and urine catecholamine = analyses.=20 </DIV> <DIV><A name=3DSec5></A> <DIV class=3DHeading3>Dosimetry</DIV> <DIV class=3DPara> <DIV>Pre-treatment dosimetry was obtained by 2 mCi of = 131I- or=20 more recently 124I-MoAbs, followed by serial whole body = Single Photon=20 Emission Computerized Tomography (SPECT) or Positron Emission Tomography = (PET)=20 scans, respectively. Distribution and activity concentrations of = radioactivity=20 in the craniospinal axis, and radiation doses to plaques of disease and=20 surrounding normal tissues were determined (Fig. <A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#Fig1">1</A>).=20 131I-MoAb radiation doses for target organs including CSF,=20 ventricles, spinal cord, normal brain and blood were based on the = assumption of=20 complete local absorption of the 131I beta radiation.=20 <DIV class=3DFigure><A name=3DFig1></A><IMG=20 alt=3DMediaObjects/11060_2009_38_Fig1_HTML.gif=20 src=3D"http://www.springerlink.com/content/p07804022q60v008/MediaObjects/= 11060_2009_38_Fig1_HTML.gif"></DIV> <DIV class=3DCapt>Fig. 1 = 124I-8H9=20 Positron Emission Tomography Scan obtained 48 hours post = Intra-Ommaya=20 injection demonstrating distribution throughout the thecal space and = activity=20 within leptomeningeal deposits </DIV> <HR> </DIV></DIV> Injections were followed by pharmacokinetic studies in CSF and blood. = Measured aliquots were counted to estimate the time-dependent activity=20 concentrations. The respective time-activity data were fit to = exponential=20 functions, which were integrated to yield the decayed area under the = curves=20 (AUCs), representing the cumulative activity concentrations in the blood = and CSF=20 as previously described [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR10">10</A></CITE>].=20 </DIV></DIV> <DIV><A name=3DSec6></A> <HR> <DIV class=3Dheading2>Results</DIV> <DIV class=3DPara> <DIV>Tables <A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#Tab2">2</A>=20 and <A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#Tab3">3</A>=20 present the clinical characteristics and demographics of the 21 patients = who=20 received this salvage regimen of surgery, craniospinal irradiation,=20 chemotherapy, and intra-Ommaya 131I-MoAb-therapy. Only 13 = (62%) of 21=20 patients had complete surgical resection of CNS lesions, with two having = bilateral craniotomies. In the remaining 8 patients, complete surgical = resection=20 was not possible because of tumor location, multiple parenchymal = metastases or=20 overt LM disease. Of the 21 patients, 16 received craniospinal = irradiation dose=20 21 Gy, 3 more recent patients received 18 Gy, and prior radiation = therapy=20 limited the dose in 2 patients (#2 and #8).<A name=3DTab2></A> <DIV class=3DCapt>Table 2 Clinical = history and=20 demographics of 21 patients with relapsed CNS NB treated with cRIT-based = salvage=20 regimen </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft> <COL align=3Dleft></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft> Pt</TH> <TH align=3Dleft> Age Dx (months)/Gender</TH> <TH align=3Dleft> MYCN, LDH</TH> <TH align=3Dleft> Sites of initial disease</TH> <TH align=3Dleft> Treatment at Dx</TH> <TH align=3Dleft> Type of relapse</TH> <TH align=3Dleft> Time to CNS relapse (months)</TH> <TH align=3Dleft> Treatment of CNS relapse</TH> <TH align=3Dleft> Dosimetry (cGy/mCi)</TH> <TH align=3Dleft> Total RIT CSF dose (cGy)</TH> <TH align=3Dleft> Disease status</TH> <TH align=3Dleft> Overall survival (months since CNS event)</TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft> 1.</TD> <TD align=3Dleft> 46, M</TD> <TD align=3Dleft> NA, 1090</TD> <TD align=3Dleft> L adr, B, BM,orbits</TD> <TD align=3Dleft> CAV =D73, P/VP =D72 thio/ABMT, S, RT, 3F8, CRA</TD> <TD align=3Dleft> 2 lesions, LM;</TD> <TD align=3Dleft> 22</TD> <TD align=3Dleft> Subtotal S, CSI 21 Gy, Irino/tmz, 131-I-3F8, = 131-I-8H9</TD> <TD align=3Dleft> 23.6=9633.8 (3F8), 20=9637 (8H9)</TD> <TD align=3Dleft> 1397</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 74</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 2.</TD> <TD align=3Dleft> 4, M</TD> <TD align=3Dleft> A, 12796</TD> <TD align=3Dleft> R. adr, pleural, liver, orbits, B, BM</TD> <TD align=3Dleft> CAV =D73, P/VP =D72 thio/ABMT, S, RT, 3F8, CRA</TD> <TD align=3Dleft> 2nd relapse, 1 right temporal lesion</TD> <TD align=3Dleft> 30</TD> <TD align=3Dleft> Subtotal S, CSI 1080 cGy, Irino/tmz, 131-I-8H9</TD> <TD align=3Dleft> 36.5=9679.5</TD> <TD align=3Dleft> 1038</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 63; MLL-associated t-AML developed 3.5 years after CNS = event=20 treated successfully</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 3.</TD> <TD align=3Dleft> 24, F</TD> <TD align=3Dleft> A</TD> <TD align=3Dleft> R RP, B, BM,</TD> <TD align=3Dleft> CAV =D73, P/VP =D72, thio/ABMT, S, RT, 3F8, CRA</TD> <TD align=3Dleft> 1 left parietal</TD> <TD align=3Dleft> 20</TD> <TD align=3Dleft> S, CSI 21 Gy, Irino/tmz, 131-I-8H9</TD> <TD align=3Dleft> 20.8=9647</TD> <TD align=3Dleft> 1423</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 53</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 4.</TD> <TD align=3Dleft> 16, M</TD> <TD align=3Dleft> A, 1132</TD> <TD align=3Dleft> R. adr, B, BM, supraclav LN</TD> <TD align=3Dleft> CAV =D73, P/VP =D72 S, RT, 3F8, CRA</TD> <TD align=3Dleft> 1 left temporal;</TD> <TD align=3Dleft> 14</TD> <TD align=3Dleft> S, CSI 21 Gy, Irino/tmz, 131-I-8H9</TD> <TD align=3Dleft> 55=9665</TD> <TD align=3Dleft> 1230</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 53</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 5.</TD> <TD align=3Dleft> 73, F</TD> <TD align=3Dleft> A, 2330</TD> <TD align=3Dleft> R. adr, L paraspinal, liver, B, BM</TD> <TD align=3Dleft> CAV =D74, P/VP =D72, S, RT, 3F8, CRA</TD> <TD align=3Dleft> 2nd relapse-BM, LM brain, spinal cord, CSF pos</TD> <TD align=3Dleft> 19</TD> <TD align=3Dleft> CSI 21 Gy, carbo, irino/tmz, 131-I-8H9</TD> <TD align=3Dleft> 43.2=9649.5</TD> <TD align=3Dleft> 2364</TD> <TD align=3Dleft> Died of infection 24 months after CNS dx; no NB at = autopsy</TD> <TD align=3Dleft> </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 6.</TD> <TD align=3Dleft> 19, F</TD> <TD align=3Dleft> A, 3165</TD> <TD align=3Dleft> R. adr, B, BM, orbits</TD> <TD align=3Dleft> CAV =D74, P/VP =D72, carbo-VP-melphalan/ABMT) S, CRA</TD> <TD align=3Dleft> 3 lesions: frontal and temporal;</TD> <TD align=3Dleft> 14</TD> <TD align=3Dleft> S (1 of 3 lesions), CSI 21 Gy, irino/tmz, = 131-I-8H9</TD> <TD align=3Dleft> 24=9638</TD> <TD align=3Dleft> 2594</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 52</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 7.</TD> <TD align=3Dleft> 23, F</TD> <TD align=3Dleft> NA, 751</TD> <TD align=3Dleft> Cervical, BM</TD> <TD align=3Dleft> PVP =D71, carbo-VP, CAV =D72, Tandem ABMT (TBI/melphalan and = cytox-carbo),=20 CRA</TD> <TD align=3Dleft> 2nd relapse; 2 lesions: cerebellar, right frontal</TD> <TD align=3Dleft> 18</TD> <TD align=3Dleft> S, CSI 21 Gy, irino/tmz, 131-I-8H9</TD> <TD align=3Dleft> 18=9635</TD> <TD align=3Dleft> 1688</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 47</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 8.</TD> <TD align=3Dleft> 48, F</TD> <TD align=3Dleft> NA</TD> <TD align=3Dleft> L adr, mediastinal, supraclavicular, BM</TD> <TD align=3Dleft> PVP x, ifos-VP =D71, CAV =D71, CV =D73, Tandem ABMT (carbo-VP, = and=20 thio-cytox), CRA</TD> <TD align=3Dleft> 1 left temporal</TD> <TD align=3Dleft> 20</TD> <TD align=3Dleft> S, CSI 1350 cGy, irino/tmz, 131-I-3F8</TD> <TD align=3Dleft> 23=9628</TD> <TD align=3Dleft> 1001</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 43</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 9.</TD> <TD align=3Dleft> 24, M</TD> <TD align=3Dleft> NA</TD> <TD align=3Dleft> R. paraspinal, B, BM</TD> <TD align=3Dleft> CAV =D73, PVP =D73, carbo-VP-melphalan/ABMT, CRA</TD> <TD align=3Dleft> 2nd relapse; 2 lesions: left frontal, right frontal</TD> <TD align=3Dleft> 35</TD> <TD align=3Dleft> S, CSI 21 Gy, irino/tmz, 131-I-8H9</TD> <TD align=3Dleft> 24=9625</TD> <TD align=3Dleft> 1857</TD> <TD align=3Dleft> BM relapse 10 months after CNS event, f/b CNS PD 14 months = later; DOD=20 35 months after CNS event</TD> <TD align=3Dleft> </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 10.</TD> <TD align=3Dleft> 29, F</TD> <TD align=3Dleft> NA, 1616</TD> <TD align=3Dleft> L adr, skull, BM</TD> <TD align=3Dleft> CAV =D73, PVP =D73, carbo-VP-melphalan/ABMT, CRA</TD> <TD align=3Dleft> Right frontal, abd disease</TD> <TD align=3Dleft> 16</TD> <TD align=3Dleft> S, CSI 21 Gy, carbo/irino/tmz, 131-I-3F8</TD> <TD align=3Dleft> 28.5</TD> <TD align=3Dleft> 1354</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 41</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 11.</TD> <TD align=3Dleft> 56, M</TD> <TD align=3Dleft> NA, 1712</TD> <TD align=3Dleft> R. adr, BM, B</TD> <TD align=3Dleft> 5 cycles high dose chemo, MIBG/ABMT, cyclo/topo, 3F8, CTV =D72, = CRA</TD> <TD align=3Dleft> Right frontal, + Bony lesion</TD> <TD align=3Dleft> 37</TD> <TD align=3Dleft> S, CSI 21 Gy, irino, irino/tmz, 131-I-3F8</TD> <TD align=3Dleft> 23.5</TD> <TD align=3Dleft> 823</TD> <TD align=3Dleft> Relapse in rib lesion at time of CNS event being treated; = AWD</TD> <TD align=3Dleft> 33</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 12.</TD> <TD align=3Dleft> 37, M</TD> <TD align=3Dleft> NA, 1161</TD> <TD align=3Dleft> L adr, B, BM</TD> <TD align=3Dleft> carbo-P/V-C/VP/V, MIBG/ABMT, 3F8, CRA</TD> <TD align=3Dleft> 2 lesions: Left and right temporal</TD> <TD align=3Dleft> 21</TD> <TD align=3Dleft> S (1 of 2 lesions), CSI 21 Gy, irino, Irino/tmz,=20 carbo/irino/tmz/cyt/VP, 131-I-8H9</TD> <TD align=3Dleft> 27.1</TD> <TD align=3Dleft> 1471</TD> <TD align=3Dleft> Relapse in BM 9 months after CNS event; DOD 30 months after CNS = event</TD> <TD align=3Dleft> </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 13.</TD> <TD align=3Dleft> 36, M</TD> <TD align=3Dleft> A</TD> <TD align=3Dleft> L adr, B, BM</TD> <TD align=3Dleft> CAV =D73, PVP =D73, carbo-VP-melphalan/ABMT, CRA</TD> <TD align=3Dleft> Right frontal</TD> <TD align=3Dleft> 32</TD> <TD align=3Dleft> S, CSI 21 Gy, irino/tmz, 131-I-8H9</TD> <TD align=3Dleft> 71.5</TD> <TD align=3Dleft> 3309</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 28</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 14.</TD> <TD align=3Dleft> 38, M</TD> <TD align=3Dleft> A, 2700</TD> <TD align=3Dleft> R. adr, B, BM</TD> <TD align=3Dleft> Cyclo/topo, CAV =D72, PVP =D71, carbo-VP-melphalan-MIBG/ABMT, = Hu 14.18-IL2,=20 irino/tmz =D72</TD> <TD align=3Dleft> 2 lesions: Right temporal and tectal; refractory systemic = NB</TD> <TD align=3Dleft> 19</TD> <TD align=3Dleft> S (1 of 2 lesions), CSI 21 Gy, irino, irino/tmz/carbo,=20 131-I-8H9</TD> <TD align=3Dleft> 35=9644</TD> <TD align=3Dleft> 2135</TD> <TD align=3Dleft> Persistent bone and BM NB; DOD 15 months after CNS = event</TD> <TD align=3Dleft> </TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 15.</TD> <TD align=3Dleft> 9, M</TD> <TD align=3Dleft> NA, 1336</TD> <TD align=3Dleft> L adr, testes, penis, BM</TD> <TD align=3Dleft> Observed=97had spontaneous regression until St 4 NB age 2.5 = years, then=20 treated with CAV =D73, PVP =D72, 3F8</TD> <TD align=3Dleft> 2nd relapse, 6 parenchymal masses</TD> <TD align=3Dleft> 35</TD> <TD align=3Dleft> CSI 21 Gy, irino, irino-tmz, 131-I-8H9</TD> <TD align=3Dleft> 147</TD> <TD align=3Dleft> 8820</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 20</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 16.</TD> <TD align=3Dleft> 30, F</TD> <TD align=3Dleft> NA</TD> <TD align=3Dleft> R. adr, liver, BM</TD> <TD align=3Dleft> CAV =D73, PVP =D72, CTV =D72, 3F8</TD> <TD align=3Dleft> L middle cranial fossa with herniation</TD> <TD align=3Dleft> 9</TD> <TD align=3Dleft> S, CSI 21 Gy, irino, irino-tmz, 131-I-8H9</TD> <TD align=3Dleft> 17.2</TD> <TD align=3Dleft> 1788</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 14</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 17.</TD> <TD align=3Dleft> 18, F</TD> <TD align=3Dleft> A</TD> <TD align=3Dleft> R. adr, thoracic, lumbar and sacral masses, right mandible, = BM</TD> <TD align=3Dleft> carbo-P/V-C/VP/V =D78 cycles, CTV =D72, 3F8</TD> <TD align=3Dleft> Cerebellar mass</TD> <TD align=3Dleft> 11</TD> <TD align=3Dleft> S, CSI 21 Gy, irino, irino-tmz, 131-I-8H9</TD> <TD align=3Dleft> 23.8</TD> <TD align=3Dleft> 2384</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 12</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 18.</TD> <TD align=3Dleft> 19, M</TD> <TD align=3Dleft> A</TD> <TD align=3Dleft> L supraclavicular node, BM, cortical = bone, malignant=20 pleural effusion</TD> <TD align=3Dleft> Cyclo/topo x2, Cisplatin/Etoposide x2, CAV x2,=20 ABMT, RT, 3F8</TD> <TD align=3Dleft> R LM cerebellopontine angle </TD> <TD align=3Dleft> 10</TD> <TD align=3Dleft> Subtotal resection, Irino-tmz x2, CSI 21 Gy,=20 131-I-8H9</TD> <TD align=3Dleft> *</TD> <TD align=3Dleft> *</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 10</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 19.</TD> <TD align=3Dleft> 5, F</TD> <TD align=3Dleft> A</TD> <TD align=3Dleft> R. adr, R rib lesion </TD> <TD align=3Dleft> Carbo/Etoposide, CAV x3, = Cisplatin/Etoposide x2, S,=20 ABMT</TD> <TD align=3Dleft> cerebellar mass</TD> <TD align=3Dleft> 18</TD> <TD align=3Dleft> S, CSI 18 Gy, Irinotmz, 131-I-8H9</TD> <TD align=3Dleft> *</TD> <TD align=3Dleft> *</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 10</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 20.</TD> <TD align=3Dleft> 40, M</TD> <TD align=3Dleft> NA</TD> <TD align=3Dleft> L adr, B, BM</TD> <TD align=3Dleft> PVPx2, CAV x3, ifos/VP, irino-carbotmz, S,=20 RT, 3F8/Glucan, CRA</TD> <TD align=3Dleft> L anterolateral frontal lobe</TD> <TD align=3Dleft> 19</TD> <TD align=3Dleft> S, CSI 18 Gy, Irinotmz, 131-I-8H9</TD> <TD align=3Dleft> *</TD> <TD align=3Dleft> *</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 9</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> 21.</TD> <TD align=3Dleft> 22, F</TD> <TD align=3Dleft> A</TD> <TD align=3Dleft> L adr, B </TD> <TD align=3Dleft> carbo-P/V-C/VP/V, S, CTV, RT, 3F8, CRA</TD> <TD align=3Dleft> R superior temporal gyrus</TD> <TD align=3Dleft> 31</TD> <TD align=3Dleft> S, CSI 18 Gy, Irino, Irino-tmz, 131-I-8H9</TD> <TD align=3Dleft> *</TD> <TD align=3Dleft> *</TD> <TD align=3Dleft> CR</TD> <TD align=3Dleft> 7</TD></TR></TBODY></TABLE> <DIV class=3DCapt> <DIV class=3DCaptCont> <DIV>3F8 anti-GD2 monoclonal antibody 3F8 treatment,=20 8H9 monoclonal antibody 3F8 treatment, adr adrenal, = ABMT=20 myeloablative treatment with autologous bone marrow rescue, A = amplified,=20 AWD alive with disease, BM bone marrow, b bones, = CAV=20 cyclophosphamide-doxorubicin-vincristine, carbo carboplatin, = CR=20 complete remission, CRA cis-retinoic acid, CSF=20 cerebrospinal fluid, CSI 2100 cGy radiation therapy, = Dx=20 diagnosis, F female, irino irinotecan, LDH serum = lactic=20 dehydrogenase (U/L), LM leptomeningeal, LN = lymphadenopathy,=20 M male, MYCN N-myc amplification status, NB = not-amplified,=20 NB neuroblastoma, P/VP cisplatin-etoposide, R = right, RT,=20 S surgical resection on bulky disease, t-AML = treatment-related acute=20 myelogenous leukemia, thio thiotepa-carboplatin, tmz = temozolomide,=20 VP etoposide </DIV></DIV> <DIV class=3DCaptCont> <DIV>*Not yet calculated </DIV></DIV></DIV><A = name=3DTab3></A> <DIV class=3DCapt>Table 3 Overall = summary of=20 21 patients treated with cRIT-based CNS treatment plan since 2003 </DIV> <TABLE border=3D1> <COLGROUP> <COL align=3Dleft> <COL align=3Dleft></COLGROUP> <THEAD> <TR class=3Dheader> <TH align=3Dleft> Characteristics</TH> <TH align=3Dleft> N </TH></TR></THEAD> <TBODY> <TR class=3Dnoclass> <TD align=3Dleft> Median age at initial diagnosis (months)</TD> <TD align=3Dleft> 29.3</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Median time to detection of CNS disease (months) from initial=20 diagnosis</TD> <TD align=3Dleft> 21.4</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Prior treatment with myeloablative chemotherapies</TD> <TD align=3Dleft> 13</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Isolated CNS disease as first relapse</TD> <TD align=3Dleft> 16</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Isolated CNS disease as second relapse</TD> <TD align=3Dleft> 3</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> CNS and systemic NB</TD> <TD align=3Dleft> 2</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> LM</TD> <TD align=3Dleft> 2</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Single parenchymal lesion</TD> <TD align=3Dleft> 11</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Multiple parenchymal lesions</TD> <TD align=3Dleft> 7</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Both LM and parenchymal</TD> <TD align=3Dleft> 2</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> CSF cytology positive</TD> <TD align=3Dleft> 1</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Gross total surgical resection</TD> <TD align=3Dleft> 13</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Treated with 21 Gy craniospinal irradiation</TD> <TD align=3Dleft> 16</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Number patients alive</TD> <TD align=3Dleft> 17</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Number in CR</TD> <TD align=3Dleft> 16 (7-74 months)</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Death from isolated CNS NB</TD> <TD align=3Dleft> 0</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Death from systemic NB</TD> <TD align=3Dleft> 2</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Death from CNS and systemic NB</TD> <TD align=3Dleft> 1</TD></TR> <TR class=3Dnoclass> <TD align=3Dleft> Median time to death from CNS detection (months) (4 = patients)</TD> <TD align=3Dleft> 26.5</TD></TR></TBODY></TABLE></DIV></DIV> <DIV><A name=3DSec7></A> <DIV class=3DHeading3>Toxicity</DIV> Craniospinal irradiation was associated with transient and = self-limited=20 somnolence syndrome. Manageable acute toxicities from chemotherapy = included=20 self-limited diarrhea following irinotecan and myelosuppression = requiring stem=20 cell support after chemotherapy in five patients. Following cRIT = injections,=20 self-limited fever, nausea and headache were seen after = 131I-3F8, or=20 after 131I-8H9 administration, transient grade 1 creatinine=20 elevation, and grade 1 and 3 transient elevated serum transaminase. No=20 significant myelosuppression was seen following cRIT injections of=20 131I-3F8 or 131I-8H9 injections at dose levels=20 10=9630 mCi. Self-limited myelosuppression was observed for=20 131I-8H9 injections ≥40 mCi. Two years after cRIT, one patient developed idiopathic = thrombocytopenic=20 purpura which resolved by 6 months. Five patients remain on oral = thyroid=20 hormone replacement for biochemical hypothyroidism attributed to = treatment.=20 Supplemental growth hormone administration for short stature has been=20 administered to one patient. Cataract removal was performed in one = patient=20 2 years after detection of CNS disease. In another patient, = MLL-associated=20 secondary leukemia emerged 3 years after cRIT, 4 years after = dura=20 relapse and 7 years from the initial NB diagnosis; successful = treatment=20 with an allogeneic bone marrow transplant followed. Among the seven patients tested with formal neurocognitive = evaluations, no=20 unexpected deficits were noted. Seventeen children attending primary = school are=20 mainstreamed in regular classes, although two patients are receiving = additional=20 early intervention services (patients #3 and 7). </DIV> <DIV><A name=3DSec8></A> <DIV class=3DHeading3>Survival</DIV> <DIV class=3DPara> <DIV>Out of 21 patients, 17 remain alive 7=9674 months (median 33) = months from the=20 time of CNS NB diagnosis (Fig. <A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#Fig2">2</A>),=20 all with no evidence of CNS disease. The longest survivor (patient #1), = having=20 had refractory bone marrow NB after myeloablative chemotherapy and then = LM=20 spread, is now 6.5 years in continuous CNS and systemic complete = remission=20 (Fig. <A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#Fig3">3</A>).=20 Three deaths occurred from non-CNS events. One patient (# 5) died of = pulmonary=20 infection 23 months after the detection of LM NB that had initially = progressed following craniospinal irradiation; she achieved a = long-standing=20 remission of disease with resolution of NB on spine MR and CSF cytology=20 following 131I-8H9; no NB in the CNS or otherwise was = detected at=20 autopsy. One patient (# 14) died of refractory lung and bone marrow NB=20 15 months after the CNS event, and another died of progressive bone = marrow=20 disease 30 months after the CNS event. Only one patient (# 9) progressed = in the=20 CNS, 14 months after the initial CNS event and 2 months after = his=20 third marrow relapse. He died of both progressive CNS and systemic = disease 35=20 months after the CNS event. As extended survival was observed in = patients=20 treated with both 131I-3F8 and escalating doses of=20 131I-8H9 on the phase I study, there was no clear therapeutic = response favoring one cRIT mAb over the other.=20 <DIV class=3DFigure><A name=3DFig2></A><IMG=20 alt=3DMediaObjects/11060_2009_38_Fig2_HTML.gif=20 src=3D"http://www.springerlink.com/content/p07804022q60v008/MediaObjects/= 11060_2009_38_Fig2_HTML.gif"></DIV> <DIV class=3DCapt>Fig. 2 Kaplan=96Meier curve=20 demonstrating overall survival in months from CNS disease detection for = 21=20 patients treated with current cRIT-based treatment plan; 17 patients are = alive=20 </DIV> <HR> <DIV class=3DFigure><A name=3DFig3></A><IMG=20 alt=3DMediaObjects/11060_2009_38_Fig3_HTML.jpg=20 src=3D"http://www.springerlink.com/content/p07804022q60v008/MediaObjects/= 11060_2009_38_Fig3_HTML.jpg"></DIV> <DIV class=3DCapt>Fig. 3 A = Relapsed=20 metastatic NB in a patient who remains progression-free, now 74+ months = since=20 detection of CNS disease B. This patient had leptomeningeal = disease and a=20 subtotal resection, followed by craniospinal irradiation and cRIT </DIV> <HR> </DIV></DIV></DIV></DIV> <DIV><A name=3DSec9></A> <HR> <DIV class=3Dheading2>Discussion</DIV> Metastatic NB remains one of the most difficult malignancies to cure. = The CNS=20 is a sanctuary site for NB. Current treatments for CNS relapses are = inadequate,=20 carrying a high morbidity and mortality rate. Few advances have affected = the=20 clinical outcome for such patients. Upfront treatment strategies = including=20 thiotepa-based myeloablative regimens for newly-diagnosed patients do = not=20 adequately treat the CNS [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR22">22</A></CITE>].=20 Novel agents that may detect and treat microscopic disease may improve = patient=20 survival. We reviewed 21 patients treated at MSKCC since 2003 for = relapsed NB=20 involving the CNS treated uniformly with an approach aimed at = eradicating bulky=20 and microscopic residual disease in the CNS, as well as minimal residual = systemic disease that may herald further relapses. Neurosurgical = intervention=20 served to decrease edema, control hemorrhage, and remove bulky tumor = prior to=20 starting radiation therapy. Although craniospinal irradiation required = daily=20 anesthesia for this very young patient population, this treatment was = well=20 tolerated in the outpatient setting, even with concurrent irinotecan. = Stem cell=20 rescue was necessary for those patients in whom bone marrow reserve was = marginal=20 at the time of CNS relapse. This is the first time intrathecal radiolabeled MoAbs have been = incorporated=20 into curative treatment strategies for patients with CNS NB. At the = current=20 doses, intraventricular administration of 131I-3F8 or=20 131I-8H9 is associated with manageable, acute side effects = including=20 transient headache, nausea, fever, and vomiting. We have established = that a=20 tumoricidal dose to the CSF can be delivered by a single injection, with = levels=20 to the blood and bone marrow below clinical toxicity. For a GD2-positive = free=20 floating tumor cell suspension, as in the case of LM disease, the = enhancement in=20 dose to the cells binding 3F8 can be as great as 77% [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR23">23</A></CITE>].=20 If one extrapolates the radiation dose to tumor cells based on their=20 preferential binding (>10:1) to these MoAbs, a substantial = therapeutic window=20 between effective tumor cell ablation and the dose received to normal = brain and=20 blood could be achieved. The extended survival of this patient population is encouraging given = the=20 rapidly fatal nature of CNS relapse=97no survivors among 11 patients, = median time=20 to death of 6.6 months=97in our previously published experience = before=20 initiation of the current treatment program [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR2">2</A></CITE>].=20 This poor survival among patients with CNS NB has been noted in other = large=20 series. Among 23 patients with recurrent metastatic CNS NB reviewed by = Matthay=20 et al. [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR3">3</A></CITE>]=20 despite treatment, 20 patients died <9.8 months and 22 of 23 by=20 13 months after the time of CNS disease detection. Shortened = survival was=20 most notable for patients with LM disease, 0.9=966 months [<CITE><A = href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR3">3</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR23">23</A></CITE>].=20 We recognize that this cohort of patients is limited by selection in = that=20 even in the cRIT-era, rapid deterioration and death may occur in some = patients=20 within days or weeks, usually from widespread refractory systemic or LM = disease,=20 precluding treatment initiation or completion. In contrast to patients = whose CNS=20 disease occurs in the setting of rapidly progressing systemic NB, CNS = disease as=20 an isolated relapse appears to be readily controllable and possibly = curable with=20 the proposed regimen, even when multiple parenchymal nodules at the time = of=20 relapse are detected. It is difficult to ascertain the impact of any individual treatment = modality=20 in this encouraging salvage regimen. Surgical debulking of parenchymal = masses=20 was possible in 62% of patients. Temozolomide-irinotecan chemotherapy = was=20 primarily used to control systemic NB, as previously reported [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR14">14</A></CITE>],=20 but is advantageous in this setting because of penetrance across the=20 blood=96brain-barrier. The integral role of craniospinal irradiation is also acknowledged. = However,=20 while it likely aids in disease control, external beam radiotherapy to = the=20 craniospinal axis and to sites of resected or unresected visible disease = has=20 been part of unsuccessful treatment programs previously reported = [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR2">2</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR3">3</A></CITE>].=20 Because of the young patient age and success of 2100 cGy for = microscopic=20 residual disease for the primary site [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR24">24</A></CITE>],=20 no patient received 2340 cGy or 3600 cGy craniospinal = irradiation, the=20 dose typically administered to patients with medulloblastoma in attempt = to=20 sterilize the thecal space. Indeed, among our 17 survivors after = cRIT-salvage, 5=20 were treated with a lower dose of radiation, 2 because of prior relapses = and=20 radiation exposure (1080 cGy and 1350 cGy), and 3 at 1800 cGy. = One=20 patient had progressive nodular enhancement of spinal cord leptomeninges = post=20 radiation (2160 cGy). Treatment response was noted after serial = injections=20 of 131I-8H9 therapy. As the target cGy delivered by cRIT is=20 increased, we believe it is safe to reduce the dose delivered by = conventional=20 external beam radiation therapy, and are now delivering 1800 cGy to = current=20 patients. We also note the encouraging preclinical data demonstrating = the=20 enhanced therapeutic effect of combination external beam radiation = therapy and=20 cRIT, compared to that observed with either therapy alone [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR25">25</A></CITE>,=20 <CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR26">26</A></CITE>].=20 This combination of reduced-dose craniospinal irradiation aimed at = controlling=20 bulk parenchymal and nodular LM disease and cRIT targeting micrometastic = NB, may=20 well be contributing to the prolonged survival seen in our patient = cohort. Several questions require focused study in the immediate future. What = is the=20 lower limit of craniospinal irradiation that can be administered with = cRIT? What=20 is the minimal total dose CSF cGy delivered by cRIT that still achieves=20 sterilization of the thecal space? Is there an advantage of 3F8, whose = acute and=20 long term toxicity have been well characterized, over 8H9? If the = external beam=20 dose of craniospinal irradiation is reduced, in all likelihood, cRIT = with 8H9=20 would be more advantageous than 3F8 given its higher mCi/injection.=20 Alternatively, cRIT with 3F8 is not associated with myelosuppression in = patients=20 with poor bone marrow reserve. The use of alternative isotopes, such as=20 alpha-emitting 225Ac-8H9 under preclinical investigation, may = further=20 improve the efficacy of cRIT with MoAbs. As 124I-8H9 PET/CT = provides=20 higher resolution and contrast images than SPECT with = 131I-8H9 for=20 distribution, targeting and dosimetry, 124I-8H9/PET appears = to be a=20 promising tool that may aid in the treatment planning for = radioimmunotherapy=20 trials for CNS malignancies. This may allow for patient-specific = dosimetry on=20 future phase II studies, where a specific total CSF cGy is desirable = [<CITE><A=20 href=3D"http://www.springerlink.com/content/p07804022q60v008/fulltext.htm= l#CR27">27</A></CITE>].=20 Our results support the importance of timely administration of = multi-modality=20 therapy including surgery and sterilization of the craniospinal axis = with=20 combined external beam radiotherapy and cRIT with 131I-3F8 or = 131I-8H9. Eliminating the sanctuary site for NB in the CNS = has=20 resulted in both long-term local=96regional and systemic disease = control. We demonstrate that a multi-modality treatment program centered on=20 radiolabeled MoAb to target radiation to CNS tumors using CSF as a = conduit=20 appears to improve the survival of patients with relapsed CNS NB, even = in the=20 presence of overt LM disease. The modest and manageable side effects of = the cRIT=20 are also noteworthy. CNS prophylaxis may be possible if the NB patient=20 population at high risk for CNS relapse can be identified at the time of = diagnosis. Such a combined multi-modality approach to improve survival = may be=20 applicable to other solid tumors metastasizing to the CNS. </DIV> <DIV class=3DAcknowledgments><SPAN=20 class=3DAcknowledgmentsHeading>Acknowledgments We= wish to=20 thank the Cyclotron-Radiochemistry Core of MSKCC and Yiauchung Sheh for=20 production and supply of the I-124. This study was supported in part by = the=20 FDA-KK-01A2, CA89935, CA89936, CA106450, CA117076, FD003089, PO1 = CA033049,=20 Robert Steel Foundation, Katie=92s Find A Cure Fund, Pediatric Cancer = Foundation,=20 Aubrey Fund, Hope Street Kids, Major Fund, Leptomeningeal Research Fund, = the=20 MSKCC Experimental Therapeutics Center and the Ludwig Center for Cancer=20 Immunotherapy.</DIV> <HR> <H2><A name=3DBib1></A>References </H2> <TABLE> <TBODY class=3DCitation> <TR vAlign=3Dtop> <TD>1.</TD> <TD><A name=3DCR1></A>Choi HS, Koh SH, Park ES, Shin HY, Ahn HS = (2005) CNS=20 recurrence following CD34+ peripheral blood stem cell = transplantation in=20 stage 4 neuroblastoma. 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Br J = Cancer=20 62:637=96642 <A=20 = href=3D"http://chemport.cas.org/cgi-bin/sdcgi?APP=3Dftslink&action=3D= reflink&origin=3Dspringer&version=3D1.0&coi=3D1%3ASTN%3A280%3= ADyaK3M%252FislCluw%253D%253D&md5=3D882a0249c8589805034379fbaf739770"= =20 target=3D_blank><IMG border=3D0 alt=3DChemPort=20 = src=3D"http://www.springerlink.com/content/p07804022q60v008/chemport_link= .gif"=20 width=3D65 height=3D20></A> <A=20 = href=3D"http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=3DRetrieve&= db=3DPubMed&dopt=3DAbstract&list_uids=3D2223581"=20 target=3D_blank><IMG border=3D0 alt=3DPubMed=20 = src=3D"http://www.springerlink.com/content/p07804022q60v008/pubmed_link.g= if"=20 width=3D65 height=3D20></A> </TD></TR> <TR> <TD> </TD></TR> <TR vAlign=3Dtop> <TD>5.</TD> <TD><A name=3DCR5></A>Kemshead JT, Papanastassiou V, Coakham HB, = Pizer BL=20 (1992) Monoclonal antibodies in the treatment of central nervous = system=20 malignancies. 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Clin Cancer Res = 5:3275s=963280s <A=20 = href=3D"http://chemport.cas.org/cgi-bin/sdcgi?APP=3Dftslink&action=3D= reflink&origin=3Dspringer&version=3D1.0&coi=3D1%3ACAS%3A528%3= ADyaK1MXnsVShtLs%253D&md5=3D4b58167f18a5c0f8946bdf58408d598e"=20 target=3D_blank><IMG border=3D0 alt=3DChemPort=20 = src=3D"http://www.springerlink.com/content/p07804022q60v008/chemport_link= .gif"=20 width=3D65 height=3D20></A> <A=20 = href=3D"http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=3DRetrieve&= db=3DPubMed&dopt=3DAbstract&list_uids=3D10541375"=20 target=3D_blank><IMG border=3D0 alt=3DPubMed=20 = src=3D"http://www.springerlink.com/content/p07804022q60v008/pubmed_link.g= if"=20 width=3D65 height=3D20></A> </TD></TR> <TR> <TD> </TD></TR> <TR vAlign=3Dtop> <TD>8.</TD> <TD><A name=3DCR8></A>Bigner DD, Brown MT, Friedman AH, Coleman RE, = Akabani=20 G, Friedman HS, Thorstad WL, McLendon RE, Bigner SH, Zhao XG, = Pegram CN,=20 Wikstrand CJ, Herndon JE II, Vick NA, Paleologos N, Cokgor I, = Provenzale=20 JM, Zalutsky MR (1998) Iodine-131-labeled antitenascin monoclonal = antibody=20 81C6 treatment of patients with recurrent malignant gliomas: phase = I trial=20 results. J Clin Oncol 16:2202=962212 <A=20 = href=3D"http://chemport.cas.org/cgi-bin/sdcgi?APP=3Dftslink&action=3D= reflink&origin=3Dspringer&version=3D1.0&coi=3D1%3ACAS%3A528%3= ADyaK1cXktV2isbc%253D&md5=3D58b3c4b58966bb0a344f49a7ba4bd09f"=20 target=3D_blank><IMG border=3D0 alt=3DChemPort=20 = src=3D"http://www.springerlink.com/content/p07804022q60v008/chemport_link= .gif"=20 width=3D65 height=3D20></A> <A=20 = href=3D"http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=3DRetrieve&= db=3DPubMed&dopt=3DAbstract&list_uids=3D9626222"=20 target=3D_blank><IMG border=3D0 alt=3DPubMed=20 = src=3D"http://www.springerlink.com/content/p07804022q60v008/pubmed_link.g= if"=20 width=3D65 height=3D20></A> </TD></TR> <TR> <TD> </TD></TR> <TR vAlign=3Dtop> <TD>9.</TD> <TD><A name=3DCR9></A>Reardon DA, Zalutsky MR, Akabani G, Coleman = RE,=20 Friedman AH, Herndon JE II, McLendon RE, Pegram CN, Quinn JA, Rich = JN,=20 Vredenburgh JJ, Desjardins A, Guruangan S, Boulton S, Raynor RH, = Dowell=20 JM, Wong TZ, Zhao XG, Friedman HS, Bigner DD (2008) A pilot study: = 131I-antitenascin monoclonal antibody 81c6 to deliver a = 44-Gy=20 resection cavity boost. 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J Clin = Oncol=20 25:5465=965470 <A = href=3D"http://dx.doi.org/10.1200/JCO.2007.11.1807"=20 target=3D_blank><IMG border=3D0 alt=3DCrossRef=20 = src=3D"http://www.springerlink.com/content/p07804022q60v008/crossref_link= .gif"=20 width=3D65 height=3D20></A> <A=20 = href=3D"http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=3DRetrieve&= db=3DPubMed&dopt=3DAbstract&list_uids=3D18048828"=20 target=3D_blank><IMG border=3D0 alt=3DPubMed=20 = src=3D"http://www.springerlink.com/content/p07804022q60v008/pubmed_link.g= if"=20 width=3D65 height=3D20></A> </TD></TR> <TR> <TD> </TD></TR> <TR vAlign=3Dtop> <TD>11.</TD> <TD><A name=3DCR11></A>Modak S, Kramer K, Gultekin SH, Guo HF, = Cheung NK=20 (2001) Monoclonal antibody 8H9 targets a novel cell surface = antigen=20 expressed by a wide spectrum of human solid tumors. 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