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Phase I Trial of BCNU Plus O6-Benzylguanine in the Treatment of Patients With Recurrent, Persistent or Progressive Cerebral Anaplastic Gliomas


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Phase I Trial of BCNU Plus O6-Benzylguanine in the Treatment of Patients With Recurrent, Persistent or Progressive Cerebral Anaplastic Gliomas


OBJECTIVES: I. Determine the maximum tolerated dose of carmustine when administered
following O6-benzylguanine in patients with recurrent, persistent, or progressive cerebral
anaplastic gliomas. II. Characterize the toxic effects associated with this treatment
regimen in these patients. III. Observe patients for clinical antitumor response when
treated with this regimen.

OUTLINE: Patients are stratified according to prior nitrosourea administration (yes or no).
(Prior nitrosoureas stratum closed) An initial cohort of 3 patients per stratum is treated
with intravenous O6-benzylguanine followed approximately 1 hour later by intravenous
carmustine every 6 weeks. Additional cohorts of 3-6 patients are treated with escalating
doses of carmustine until dose limiting toxicity (DLT) is observed. The maximum tolerated
dose is defined as the dose at which no more than 1 of 6 patients experiences DLT. Courses
are repeated every 6 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 24-56 patients (12-28 per stratum) will be accrued in 12
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven recurrent, persistent, or progressive
glioblastoma multiforme or anaplastic astrocytoma diagnosed by biopsy/resection Evaluable
residual disease by MRI or CT scan

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 Hepatic: SGOT no greater than 2.5 times upper limit of
normal Bilirubin within normal limits Renal: Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance greater than 60 mL/min BUN no greater than 25 mg/dL Pulmonary: DLCO
greater than 80% predicted Other: Not pregnant or nursing Fertile patients must use
effective contraceptive method during and for 2 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy (6 weeks since prior nitrosourea, procarbazine, or mitomycin) and
recovered Endocrine therapy: Concurrent corticosteroid therapy must be stable for at least
1 week prior to study, if clinically possible Radiotherapy: At least 4 weeks since prior
radiotherapy and recovered Surgery: Not specified

Type of Study:

Interventional

Study Design:

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:

CDR0000066327

NCT ID:

NCT00003348

Start Date:

May 1998

Completion Date:

August 2000

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location
Duke Comprehensive Cancer Center Durham, North Carolina  27710