Chemotherapy in Treating Patients With Recurrent Malignant Glioma

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of topotecan plus carmustine in patients with recurrent primary malignant glioma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Carmustine; Topotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven recurrent primary malignant glioma

• Measurable recurrent or residual primary central nervous system neoplasm confirmed by MRI

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance Status:

• Karnofsky at least 60%

Hematopoietic:

• Hematocrit greater than 29%

• ANC greater than 1,500/mm^3

• Platelet count greater than 125,000/mm^3

Hepatic:

• SGOT less than 1.5 times upper limit of normal (ULN)

• Bilirubin less than 1.5 times ULN

Renal:

• Creatinine less than 1.5 mg/dL

• BUN less than 25 mg/dL

Other:

• Not pregnant

• Effective contraceptive method must be used for the duration of the study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy within 6 weeks of study

• No prior topotecan or carmustine treatment failure

• No more than 1 prior chemotherapy regimen

Endocrine therapy:

• Patients taking corticosteroids must be on stable dose for at least 2 weeks prior to study and the dose should not escalate over entry level

Radiotherapy:

• No prior radiotherapy within 6 weeks of study

Surgery:

• No prior surgical resection within 3 weeks of study

Other:

• No concurrent medication that may interfere with study results