PHASE I STUDY OF ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT BRAIN TUMORS
- Determine the toxic effects of intracranial iodine I 131 labeled anti-tenascin
monoclonal antibody 81C6 in patients with primary or metastatic anaplastic gliomas.
- Determine the objective therapeutic response of these patients treated with this
OUTLINE: This is a dose escalation study of iodine I 131 labeled anti-tenascin monoclonal
antibody 81C6 (MOAB 81C6). Patients are stratified by prior external beam radiotherapy (yes
Patients receive iodine I 131 labeled MOAB 81C6 intraventricularly followed by unlabeled
MOAB 81C6 intraventricularly.
Cohorts of 3-6 patients receive escalating doses of iodine I 131 labeled MOAB 81C6 until the
maximum tolerated dose is determined. The MTD is defined as the highest dose preceding that
at which 3 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 2 years, every 2 months for 2 years, and then every 3
PROJECTED ACCRUAL: A total of 3-6 patients per cohort will be accrued for this study.
Primary Purpose: Treatment
Darell D. Bigner, MD, PhD
Duke Cancer Institute
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|