Phase 2 Trial of BCNU Plus O6-Benzylguanine (NSC 637037) in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
Phase 2 Trial of BCNU Plus O6-Benzylguanine (NSC 637037) in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme
OBJECTIVES:
- Determine the activity of carmustine and O6-benzylguanine in patients with newly
diagnosed supratentorial glioblastoma multiforme not requiring immediate radiotherapy.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive O6-benzylguanine IV over 1 hour followed approximately 1 hour
later by carmustine IV over 1 hour on day 1. Treatment repeats every 6 weeks for a maximum
of 3 courses in the absence of disease progression or unacceptable toxicity. Patients are
then referred for radiotherapy. Patients who demonstrate tumor response after completion of
the third course of chemotherapy receive 6 additional courses after completion of
radiotherapy.
PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed supratentorial glioblastoma multiforme not
requiring immediate radiotherapy
- Measurable residual disease on a contrast-enhanced MRI or CT scan (for patients with
a medical contraindication for MRI) with a baseline scan obtained at the
corticosteroid dose the patient is receiving on the day of treatment
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin greater than 10 g/dL
Hepatic
- Bilirubin normal
- SGOT no greater than 2.5 times upper limit of normal
Renal
- Creatinine no greater than 1.5 mg/dL
- BUN no greater than 25 mg/dL
Pulmonary
- DLCO greater than 75% predicted
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- See Disease Characteristics
- Concurrent corticosteroids allowed if on stable dose for 3 days before study
Radiotherapy
- See Disease Characteristics
Surgery
- No more than 28 days since prior surgical resection or biopsy
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Henry S. Friedman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Duke Cancer Institute
Authority:
United States: Federal Government
Study ID:
3318
NCT ID:
NCT00046878
Start Date:
Completion Date:
August 2002
Related Keywords:
- Brain and Central Nervous System Tumors
- adult glioblastoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
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