Metastatic Cancer Clinical Trial
Official title:
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
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or
deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody
therapy in treating patients who have primary or metastatic brain cancer.
OBJECTIVES:
- 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
regimen.
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
vs no).
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
months thereafter.
PROJECTED ACCRUAL: A total of 3-6 patients per cohort will be accrued for this study.
;
Primary Purpose: Treatment
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