Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas

• Status: Completed
• Trial end date: 2002-07-01
• 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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of carmustine wafers plus irinotecan in treating patients with recurrent supratentorial high grade gliomas.

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

Details

• Lead Sponsor: Duke University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Carmustine; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed recurrent supratentorial glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma

• Must be able to undergo surgical resection

• At least 1 bidimensionally measurable lesion documented on Gd-MRI within 72 hours after surgical implantation of Gliadel wafers

• Not requiring immediate radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Greater than 12 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 125,000/mm^3

• Hematocrit at least 29%

Hepatic:

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

• SGOT or SGPT less than 2.5 times ULN

• Alkaline phosphatase less than 2 times ULN

Renal:

• BUN less than 1.5 times ULN

• Creatinine less than 1.5 times ULN

Neurological:

• Must be neurologically stable

Other:

• HIV negative

• No AIDS-related illness

• No nonmalignant systemic disease that would make patient a poor medical risk

• No acute infection requiring intravenous antibiotics

• Not pregnant or nursing

• Negative pregnancy test 24 hours prior to study

• Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior irinotecan

• At least 6 weeks since chemotherapy unless there is unequivocal evidence of tumor progression after chemotherapy

Endocrine therapy:

• At least 1 week of nonincreasing dose of steroids prior to study

Radiotherapy:

• At least 6 weeks since radiotherapy unless there is unequivocal evidence of tumor progression after radiotherapy

• No concurrent radiotherapy

Surgery:

• Not specified