Clinical Trial Finder

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

OBJECTIVES:

• - Define the maximum tolerated dose of irinotecan given in combination with Gliadel wafers (carmustine) in patients with recurrent glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma.

• - Define the toxicity of irinotecan given in combination with Gliadel wafers in these patients.

OUTLINE: This is a dose escalation study. All patients undergo surgical resection. At the time of surgery, up to eight Gliadel wafers (containing carmustine) are implanted in the resected tumor cavity. Cohorts of 3 patients each receive escalating doses of irinotecan IV over 90 minutes once weekly within 3 weeks after Gliadel wafer implantation. One course of treatment consists of 4 weeks of irinotecan and 2 weeks of rest. If 1 patient experiences dose limiting toxicity (DLT) at a dose level, an additional 3 patients are entered at that same dose level. If 2 patients experience DLT, the maximum tolerated dose (MTD) has been surpassed and a total of 6 patients are treated at the previous dose level. The MTD is defined as the highest dose in which no more than 1 of 6 patients experiences DLT. Treatment continues for up to 12 courses in the absence of unacceptable toxicity and disease progression. Patients are followed for at least 4 months. PROJECTED ACCRUAL: Approximately 18 patients will be accrued into this study over 9 months.