Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

• Status: Terminated
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining biological therapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining poly-ICLC with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: North American Brain Tumor Consortium; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Poly ICLC

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed intracranial glioblastoma multiforme (GBM) or gliosarcoma by biopsy or resection within the past 28 days

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• More than 8 weeks

Hematopoietic

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic

• Bilirubin less than 2 times upper limit of normal (ULN)

• SGOT less than 2 times ULN

Renal

• Creatinine less than 1.5 mg/dL

Other

• No significant medical illness that cannot be controlled adequately with appropriate therapy or that would compromise tolerability of study therapy

• No other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that disease for at least 3 years

• No active infection

• No disease that would obscure toxicity or dangerously alter drug metabolism

• No other serious concurrent medical illness

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior polifeprosan 20 with carmustine implant (Gliadel wafer)

• No concurrent chemotherapy

Endocrine therapy

• Concurrent corticosteroids to treat symptoms or prevent complications are allowed

Radiotherapy

• No prior radiotherapy to the brain

• No concurrent stereotactic radiosurgery

• No concurrent brachytherapy

Surgery

• See Disease Characteristics

Other

• No prior cytotoxic or noncytotoxic drug therapy for GBM

• No prior experimental drug therapy for GBM

• No other concurrent cytotoxic or noncytotoxic drug therapy for GBM

• Concurrent analgesics, antiepileptics, or other drugs to treat symptoms or prevent complications are allowed