Expired Study
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Durham, North Carolina 27710


Purpose:

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. This may be effective treatment for primary or metastatic brain tumors. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients with primary or metastatic brain tumors.


Study summary:

OBJECTIVES: - Determine the toxicity of monoclonal antibody (MAb) Astatine At 211 Antitenascin Human/Mouse Chimeric 81C6 (At 211 MAb 81C6) therapy delivered via the intracranial resection cavity in patients with recurrent primary or metastatic malignant brain tumors. - Identify objective therapeutic responses of these patients to this treatment. OUTLINE: This is a dose escalation study. Patients undergo surgical resection of their tumor at which time an indwelling intracranial resection cavity catheter is surgically placed. Patients receive one dose of astatine At 211 antitenascin monoclonal antibody 81C6 (At 211 MAb 81C6) via the intralesional catheter. Cohorts of 3-6 patients are treated at escalating doses of At 211 MAb 81C6. The maximum tolerated dose is the highest dose at which no more than 3 of 6 patients experience dose limiting toxicity. Patients are followed initially at 4 weeks, then at approximately 12 weeks, at 24 weeks, and then every 12 weeks for 1 year. PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 18-24 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed newly diagnosed or recurrent supratentorial primary or metastatic malignant brain tumor - Measurable disease by MRI or CT scan - Candidate for surgical resection - Extension of tumor no more than 1.0 cm beyond the margin of the surgical cavity - Demonstrated reactivity of tumor cells with tenascin by immunohistology with either a polyclonal rabbit antibody or the monoclonal mouse antibody - No infratentorial tumors, diffusely infiltrating tumors, tumors with subependymal spread, or multifocal tumors PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 50-100% Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count greater than 1000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 1.5 mg/dL - Alkaline phosphatase less than 1.5 times normal - SGOT less than 1.5 times normal Renal: - Creatinine less than 1.2 mg/dL Other: - Not pregnant or nursing - 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 progression Endocrine therapy: - Concurrent corticosteroids allowed, but must be on stable dose for at least 1 week Radiotherapy: - At least 3 months since prior radiotherapy to site of measurable disease in the CNS Surgery: - See Disease Characteristics


NCT ID:

NCT00003461


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 19, 2017

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