a targeted radiation boost dose of 44Gy to the resection cavity perimeter of
patients with newly diagnosed malignant brain tumors via an individualized dose
of 131-iodine labeled murine antitenascin monoclonal antibody 81C6: Preliminary
results of a phase II trial
Shafman, D. A. Reardon, G. Akabani, A. Friedman, H. S. Friedman, J. Sampson, T.
Wong, X.-G. Zhao, M. Zalutsky, D. D. Bigner
Univ Med Ctr, Durham, NC
efficacy and tolerance of 131I murine antitenascin monoclonal
antibody 81C6 (m81C6) when injected into the surgically created resection cavity
of patients with malignant brain tumors has been established in prior phase I (Cokgor
JCO 18:3862,2000) and phase II (Reardon JCO 20:1389,2002) studies.
Analysis of dosimetry data obtained from patients treated on these studies
demonstrates that a boost dose of 44 Gy by 131I-m81C6 to the
resection cavity perimeter achieved optimal tumor control while minimizing risk
of normal brain injury (Akabani IJROBP 46:947,2000).
The current phase II study is designed to assess the efficacy of 131I-m81C6
administered at a dose predicted to achieve a 44 Gy boost to the resection
cavity perimeter based on a pre-treatment dosimetry analysis performed for each
Eligible patients must have a histologically-proven, newly diagnosed, unifocal,
malignant CNS tumor located in the supratentorial compartment that demonstrates
immunoreactivity with 81C6.
Patients must undergo a gross total resection and have no evidence of
communication between the resection cavity and CSF space.
Eligible patients must have a Karnofsky performance status > 60% as well as
adequate bone marrow, hepatic and renal function.
A dosimetry study with 10 mCi of 131I-m81C6 will be performed in all
patients to determine the dose of 131I-m81C6 needed to achieve a 44
Gy boost to the resection cavity perimeter.
To date five patients have been treated including 4 with newly diagnosed
glioblastoma multiforme (GBM) and one with an anaplastic astrocytoma.
Four are male and the median age is 54 years (range, 24-70).
The median 131I-m81C6 dose administered is 42.7 Gy (range, 25-48 Gy).
No significant toxicity has occurred with a median follow-up of 24.9 weeks
To date a 44 ±
10% Gy radiation boost has been successfully administered to the resection
cavity perimeter of all patients enrolled.
Accrual is ongoing to this study and an updated analysis of outcome will be
2003 American Society of Clinical Oncology All rights reserved worldwide