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Results of a phase II study of 131
Iodine-labeled anti-tenascin murine monoclonal antibody 81C6 (m81C6)
administered to deliver a targeted radiation boost dose of 44 Gy to
the surgically created cystic resection cavity perimeter in the
treatment of patients with newly diagnosed primary and metastatic
brain tumors
J. J. Vredenburgh, D.
Reardon, G. Akabani, A. Friedman, H.
Friedman, R. McLendon, J. Quinn, J.
Rich, M. Zalutsky and D. Bigner
Duke Univ Medcl Ctr, Durham, NC
Prior trials using a "fixed"
dose of 131I anti-tenascin monoclonal antibody
81C6 (131I-81C6) administered into the surgically created
resection cavity (SCRC) of patients with either newly diagnosed
or recurrent malignant glioma have shown encouraging survival
and acceptable toxicity.
Dosimetry analyses from these studies predict that the
delivery of a "targeted" 44 Gy boost to the SCRC
by 131I-81C6 may lower toxicity and possibly improve
outcome compared to the "fixed" dose
regimen.
The current study was designed to evaluate the efficacy and
toxicity of administering a dose of 131I-81C6 to
achieve a "targeted" 44 Gy boost to the SCRC
perimeter.
Eligibility criteria: adults with newly diagnosed and
previously untreated MG; gross total resection; lack of communication
between the SCRC and the CSF space; KPS > 60%; and
adequate bone marrow, kidney and hepatic function.
A pretreatment dosimetry study with approximately 0.5mCi of
131I-81C6 is performed to determine the
therapeutic dose of 131I-81C6 required to achieve the
44 Gy "targeted" boost in each individual patient.
Following the therapeutic dose of 131I-81C6 all
patients undergo conventional XRT and systemic
chemotherapy.
21 patients have been treated to date including 15 with GBM
and 6 with AA/AO.
The median age was 49 years (24–70) and 76% were
male.
The median dose of 131I-81C6 administered was
62mCi (25–150).
20 patients have successfully achieved a 44 Gy (+/–10%)
boost to the SCRC perimeter.
Toxicity has been limited to grade 3 reversible hematologic
toxicity in 15%.
No episodes of grade 4 toxicity have occurred.
With a median follow-up of 62.7 weeks, the median survival
for patients with newly diagnosed GBM is 93.9 weeks and the
median survival for the AA/AO patients has not been achieved.
The administration of this 131-I-81C6 to achieve a 44 Gy
"targeted" boost is feasible and associated with encouraging
survival and low toxicity indicating that this approach deserves
further evaluation.
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