Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Brain and Central Nervous System Tumors, Metastatic Cancer

Intervention / Treatment
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* Radiation: iodine I 131 monoclonal antibody 81C6


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven primary or metastatic malignant supratentorial anaplastic glioma 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 PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Karnofsky 50-100% Hematopoietic: Absolute neutrophil count greater than 1,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 1.5 times normal Alkaline phosphatase less than 1.5 times normal Renal: Creatinine less than 1.2 mg/dL Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior chemotherapy unless unequivocal evidence of tumor progression Endocrine therapy: Corticosteroids allowed if at lowest possible dose and dose stable for at least 10 days prior to entry Radiotherapy: At least 3 months since prior radiotherapy to site of measurable disease unless unequivocal evidence of tumor progression Surgery: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: iodine I 131 monoclonal antibody 81C6|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult pilocytic astrocytoma, childhood supratentorial ependymoma, recurrent childhood brain tumor, recurrent adult brain tumor, adult medulloblastoma, adult glioblastoma, tumors metastatic to brain, childhood high-grade cerebral astrocytoma, adult anaplastic astrocytoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult subependymoma, adult ependymoblastoma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood medulloblastoma, newly diagnosed childhood ependymoma, recurrent childhood ependymoma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma