Expired Study
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New York, New York 10016


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.

Study summary:

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)


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



Primary Contact:

Study Chair
Michael L. Gruber, MD
New York University School of Medicine

Backup Contact:


Location Contact:

New York, New York 10016
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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