Carmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma

NCT ID: NCT00005081

Last Updated: 2014-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2001-04-30

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining carmustine and O6-benzylguanine in treating patients who have recurrent or progressive glioma.

Detailed Description

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT

Interventions

O6-benzylguanine

Intervention Type: DRUG

carmustine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry S. Friedman, MD

Role: STUDY_CHAIR

Duke Cancer Institute

Locations

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

DUMC-0059-00-1

Identifier Type: -

Identifier Source: secondary_id

DUMC-T98-0059

Identifier Type: -

Identifier Source: secondary_id

NCI-T98-0059

Identifier Type: -

Identifier Source: secondary_id

CDR0000067688

Identifier Type: -

Identifier Source: secondary_id

0059

Identifier Type: -

Identifier Source: org_study_id