RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

Condition	Treatment or Intervention	Phase
adult glioblastoma multiforme Quality of Life	Drug: carmustine  Drug: cisplatin  Drug: etoposide	Phase II

Further Study Details: 

OBJECTIVES: I. Evaluate the efficacy of carmustine, cisplatin, and etoposide administered prior to and during radiotherapy in patients with newly diagnosed high grade glioblastoma multiforme.

II. Assess the toxicities of this treatment regimen in this patient population.

III. Assess fatigue, depression, and excessive daytime somnolence in terms of incidence, duration, and relation to age, tumor type, tumor site, cancer therapy, and symptoms in this patient population.

IV. Evaluate the quality of life of these patients.

PROTOCOL OUTLINE: Patients receive pre-irradiation chemotherapy consisting of carmustine IV over 1 hour on days 1-3 and oral etoposide on days 1-21 and 29-49 immediately followed by cisplatin IV over 1-2 hours on days 1-3 and 29-31. Treatment repeats every 8 weeks for 2 courses. Patients receive concurrent cranial radiotherapy daily over 8 weeks during course 2. Patients then receive carmustine IV over 1-2 hours every 8 weeks for 4 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before the study, prior to each treatment course, every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years.

Patients are followed every 4 months for 1 year, every 6 months for 4 years, annually for 5 years, and then for survival.

PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 15 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed newly diagnosed glioblastoma multiforme
• No oligodendrogliomas or oligoastrocytomas

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: Concurrent steroids allowed
• Radiotherapy: No prior radiotherapy
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: Not specified
• Hematopoietic: WBC at least 3,500/mm3; Platelet count at least 130,000/mm3
• Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT no greater than 2 times ULN
• Renal: Creatinine no greater than 0.5 mg/dL above ULN
• Other: No uncontrolled infection; No other major medical conditions; No other concurrent malignancy except superficial skin cancers; Must be able to read English (quality of life assessment only); No other problem that may preclude quality of life assessment; Not pregnant or nursing; Fertile patients must use effective contraception

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      CentraCare Clinic, Saint Cloud,  Minnesota,  56303,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States
North Dakota
      Altru Health Systems, Grand Forks,  North Dakota,  58201,  United States
      Quain & Ramstad Clinic, P.C., Bismarck,  North Dakota,  58501,  United States
Ohio
      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States
Pennsylvania
      CCOP - Geisinger Clinical and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57105-1080,  United States
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States

Study chairs or principal investigators

Timothy J. Moynihan,  Study Chair,  North Central Cancer Treatment Group   

Study ID Numbers:  CDR0000067206; NCCTG-987252
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003996
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08