Expired Study
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Durham, North Carolina 27710


Purpose:

RATIONALE: Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances, such as radioactive iodine, to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody after radiation therapy in treating patients with newly diagnosed primary brain tumors that can be surgically resected.


Study summary:

OBJECTIVES: - Determine the toxicity of iodine I 131 monoclonal antibody 81C6 delivered via the intracranial resection cavity in patients with newly diagnosed primary malignant brain tumors after surgery and radiotherapy. - Determine objective therapeutic responses of these patients to this treatment. OUTLINE: This is a dose escalation study of iodine I 131 antitenascin monoclonal antibody 81C6 (I 131 MAb 81C6). Within 2-4 weeks after completion of external beam radiotherapy, patients undergo surgical resection of the tumor or brain metastasis, at which time an indwelling intracranial resection cavity catheter is placed. A single dose of I 131 MAb 81C6 is delivered via the intralesional catheter. Cohorts of 3-6 patients receive escalating doses of I 131 MAb 81C6 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. After the MTD has been established, patients in the phase II portion of the study receive therapy as in phase I. Beginning 4 weeks after the monoclonal antibody treatment, patients begin chemotherapy. Patients receive carmustine IV over 1 hour on day 1 and irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment is repeated every 6 weeks for at least 4 courses in the absence of disease progression. Patients are followed initially at 4 weeks, then every 6 weeks for 1 year. PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed newly diagnosed supratentorial primary malignant brain tumor - No infratentorial tumors, infiltrating tumors, tumors with subependymal spread, or multifocal tumors - Candidate for surgical resection - Prior external beam radiotherapy to site of measurable disease or resection site in the nervous system required - Presence of tenascin in the tumor demonstrated by immunohistology with either a polyclonal rabbit antitenascin antibody or monoclonal antibody 81C6 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 - Lactic dehydrogenase 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 - No iodine allergies PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Concurrent corticosteroids allowed, but must be on stable dose for at least 10 days Radiotherapy: - See Disease Characteristics Surgery: - See Disease Characteristics


NCT ID:

NCT00003484


Primary Contact:

Study Chair
Darell D. Bigner, MD, PhD
Duke University


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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