Expired Study
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Durham, North Carolina 27710


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00002752


Primary Contact:

Study Chair
Darell D. Bigner, MD, PhD
Duke Cancer Institute


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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