Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme

NYU Langone Health

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 II trial to study the effectiveness of combining carboplatin with irinotecan in treating patients who have glioblastoma multiforme.

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 60 and over), ECOG performance status (0-1 vs 2), and extent of resection (total vs 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)

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Brain and Central Nervous System Tumors

Interventions

carboplatinDRUG

irinotecan hydrochlorideDRUG

radiation therapyRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, United States

Data from ClinicalTrials.gov

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