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

Duke University

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Brain and Central Nervous System Tumors

Interventions

carmustineDRUG

irinotecan hydrochlorideDRUG

polifeprosan 20 with carmustine implantDRUG

surgical procedurePROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Data from ClinicalTrials.gov

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