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.
- 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.
- Histologically proven primary or metastatic malignant supratentorial anaplastic
- Newly diagnosed or recurrent
- No diffusely infiltrating or multifocal tumor
- No tumor with subependymal spread
- Resection of glioma and placement of an intralesional catheter into the surgical
cavity required before study
- Measurable lesion on enhanced CT scan or MRI
- No measurable enhancing lesion greater than 1.0 cm beyond cavity margin
- Neoplastic cell reactivity with tenascin demonstrated by immunohistology with either
a polyclonal rabbit antibody or a monoclonal murine antibody
- 3 and over
- Karnofsky 50-100%
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 100,000/mm^3
- Bilirubin less than 1.5 mg/dL
- AST less than 1.5 times normal
- Alkaline phosphatase less than 1.5 times normal
- Creatinine less than 1.2 mg/dL
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- Not specified
- At least 6 weeks since prior chemotherapy unless unequivocal evidence of tumor
- Corticosteroids allowed if at lowest possible dose and dose stable for at least 10
days prior to entry
- At least 3 months since prior radiotherapy to site of measurable disease unless
unequivocal evidence of tumor progression
- See Disease Characteristics