Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: bleomycin; Ommaya reservoir; radiation therapy
Intervention description: 60.0 Gy/30 fractions x 2.0 Gy. For the first 46 Gy/23 fractions the treatment volume should include the volume of contrast-enhancing lesion and surrounding edema on pre-operative CT/MRI scan plus a 2 centimeter margin. If no edema is present, the margin should be 2.5 cm. After 46.0 Gy, the tumor volume should include the contrast-enhancing lesion (without edema) on the pre-surgery MRI/CT scan plus a 2.5 centimeter margin.
Intervention MeSH terms: Bleomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

Summary:

      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
      chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
      die. Combining radiation therapy with chemotherapy may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by bleomycin
      in treating adult patients who have newly diagnosed supratentorial glioblastoma multiforme.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed supratentorial glioblastoma multiforme (with areas of
             necrosis) by surgical biopsy or excision within 4 weeks of study

          -  Tumor and/or any associated edema limited to one hemisphere and unifocal

          -  No gross invasion of a ventricular surface

          -  Tumor accessible

          -  No other astrocytoma

          -  No multifocal or recurrent malignant glioma

          -  No disease below the tentorium or beyond the cranial vault

        PATIENT CHARACTERISTICS:

        Age:

          -  Adult

        Performance status:

          -  Zubrod 0-1

        Life expectancy:

          -  At least 8 weeks

        Hematopoietic:

          -  Hemoglobin at least 10 g/dL (transfusion allowed)

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic:

          -  Bilirubin no greater than 2.0 mg/dL

          -  Serum glutamic-oxaloacetic transaminase (SGOT) or Serum glutamic-pyruvic transaminase
             (SGPT) no greater than 2 times normal

        Renal:

          -  Blood Urea Nitrogen (BUN) no greater than 25 mg/dL

          -  Creatinine no greater than 1.5 mg/dL

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No hypersensitive or idiosyncratic reaction to bleomycin

          -  No other prior malignancies within the past 2 years except nonmelanomatous skin cancer
             or carcinoma in situ of the cervix or urinary bladder

          -  No other major medical illness or psychiatric impairment that would preclude study
             participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  No prior chemotherapy for glioblastoma multiforme

          -  No prior radiosensitizer for glioblastoma multiforme

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior radiotherapy to the head or neck resulting in overlapping radiotherapy fields

        Surgery:

          -  See Disease Characteristics

          -  Recovered from prior surgery