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


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


OBJECTIVES: I. Determine the activity of carmustine and O6-benzylguanine in patients with
recurrent or progressive glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma
resistant to nitrosourea. II. Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients receive O6-benzylguanine IV over 1 hour, followed 1 hour later by
carmustine IV over 1 hour on day 1. Treatment repeats every 6 weeks in the absence of
disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 12-18
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed recurrent or progressive glioblastoma
multiforme, anaplastic astrocytoma, or gliosarcoma Resistant to nitrosourea (defined as
progressive or recurrent disease within 8 weeks of receiving nitrosourea) Measurable
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 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 80% predicted
Other: Not pregnant or nursing Fertile patients must use effective contraception during
and for 2 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 4 weeks since prior chemotherapy At least 6 weeks since prior
nitrosourea, procarbazine, or mitomycin and recovered No prior nitrosourea greater than
1,200 mg/m2 Endocrine therapy: Concurrent stable dose corticosteroids allowed if on for at
least two weeks prior to study Radiotherapy: At least 4 weeks since prior radiotherapy
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:

0059 (CDR0000067688)

NCT ID:

NCT00005081

Start Date:

August 2000

Completion Date:

April 2001

Related Keywords:

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

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710