Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: poly ICLC
Intervention MeSH terms: Poly ICLC
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

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.
    

Eligibility 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