Durham, North Carolina 27710

  • Neuroblastoma


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.


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



Primary Contact:

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

Backup Contact:


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: June 20, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.