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A Phase II Trial of Pre-Irradiation Chemotherapy With BCNU, Cisplatin and Oral Etoposide Combined With Radiation Therapy in the Treatment of Grade 4 Astrocytoma (Glioblastoma)

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

Thank you

Trial Information

A Phase II Trial of Pre-Irradiation Chemotherapy With BCNU, Cisplatin and Oral Etoposide Combined With Radiation Therapy in the Treatment of Grade 4 Astrocytoma (Glioblastoma)

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.

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed glioblastoma multiforme
No oligodendrogliomas or oligoastrocytomas

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Timothy J. Moynihan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

May 1999

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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