Clinical Trial Finder

DISEASE CHARACTERISTICS:

• - Histologically confirmed glioblastoma multiforme.

• - Measurable disease.

• - No CNS metastases or carcinomatous meningitis.

PATIENT CHARACTERISTICS: Age:

• - 18 and over.

Performance status:

• - ECOG 0-2 OR.

• - Karnofsky 70-100% Life expectancy: - At least 12 weeks.

Hematopoietic:

• - Granulocyte count greater than 1,500/mm^3.

• - Platelet count greater than 100,000/mm^3.

• - Hemoglobin at least 9.0 g/dL.

Hepatic:

• - Bilirubin no greater than 1.5 mg/dL.

• - SGOT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver involvement) - No known Gilbert's syndrome.

Renal:

• - Creatinine no greater than 1.5 mg/dL.

Cardiovascular:

• - No myocardial infarction within the past 6 months.

• - No congestive heart failure requiring therapy.

Other:

• - HIV negative.

• - No active or uncontrolled infection.

• - No psychiatric disorder that would preclude study.

• - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.

• - No uncontrolled diabetes mellitus (i.e., random blood sugar of 200 mg or more) - No other severe disease that would preclude study.

• - Not pregnant or nursing.

• - Negative pregnancy test.

• - Fertile patients must use effective contraception.

PRIOR CONCURRENT THERAPY: Biologic therapy:

• - No prior immunotherapy or biologic therapy.

• - No concurrent sargramostim (GM-CSF) - No concurrent filgrastim (G-CSF) with course 1.

• - No concurrent immunotherapy.

Chemotherapy:

• - No prior chemotherapy.

• - No other concurrent chemotherapy.

Endocrine therapy:

• - Must have maintained a stable or decreasing dose of corticosteroids for 2 weeks prior to study.

• - Concurrent corticosteroids for cerebral edema allowed.

• - No concurrent anticancer hormonal therapy.

Radiotherapy:

• - No prior radiotherapy.

• - No concurrent radiotherapy.

Surgery:

• - At least 2 weeks since prior surgery.

Other:

• - No other concurrent investigational agent or participation on any other clinical study.

• - No concurrent immunosuppressive drugs.

• - No concurrent phenobarbital or valproic acid.

• - No concurrent anticonvulsants except carbamazepine or gabapentin.

- No concurrent prochlorperazine on day of irinotecan treatment

OBJECTIVES:

• - Determine the maximum tolerated dose (MTD) of carboplatin and irinotecan in patients with glioblastoma multiforme.

(Phase I closed to accrual as of 6/24/02)

• - Determine the toxic effects of this regimen in these patients.

• - Determine the objective response in patients treated with the established MTD of this regimen.

• - Determine time to tumor progression and survival of patients treated with this regimen.

OUTLINE: This is a dose-escalation study. Patients in the phase II portion of the study are stratified according to age (under 60 vs.#46;60 and over), ECOG performance status (0-1 vs.#46;2), and extent of resection (total vs.#46;subtotal). (Phase I closed to accrual as of 6/24/02) Within 4 weeks of surgery, patients receive carboplatin IV over 30 minutes followed by irinotecan IV over 90 minutes on day 1. Treatment repeats every 4 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive carboplatin and irinotecan at the recommended phase II dose. (Phase I closed to accrual as of 6/24/02) After chemotherapy, all patients undergo radiotherapy. Patients are followed for 30 days. PROJECTED ACCRUAL: A total of 24-107 patients (3-54 for phase I and 21-53 for phase II) will be accrued for this study. (Phase I closed to accrual as of 6/24/02)