Treatment > Radioimmunotherapy

Meeting Abstract

Delivering 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

T. Shafman, D. A. Reardon, G. Akabani, A. Friedman, H. S. Friedman, J. Sampson, T. Wong, X.-G. Zhao, M. Zalutsky, D. D. Bigner

Duke Univ Med Ctr, Durham, NC

The 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 patient.
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 (range, 35.7-13.4).
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 presented.

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