Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Darell D. Bigner, MD, PhD
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Carmustine; Immunoglobulins; Irinotecan

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