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Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme



Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme

For Condition: adult glioblastoma multiforme
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Kaplan Cancer Center
Synopsis: 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/II trial to study the effectiveness of combining carboplatin and irinotecan in treating patients who have glioblastoma multiforme.
Details: OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of carboplatin and irinotecan in patients with glioblastoma multiforme. II. Determine the toxic effects of this regimen in these patients. III. Determine the objective response in patients treated with the established MTD of this regimen. IV. Determine time to tumor progression and survival of patients treated with this regimen. PROTOCOL 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). 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. 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed glioblastoma multiforme - Measurable disease - No CNS metastases or carcinomatous meningitis --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 --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/mm3; Platelet count greater than 100,000/mm3; 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MichaelGruber,  Study Chair,  Kaplan Cancer Center

NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City,  New York,  10016
United States
 


Additional Information:
Study ID Numbers:  CDR0000068435;  P-UPJOHN-986475197,NCI-G00-1909,NYU-9902
Study Start Date: May 1999
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010036

Other Adult Glioblastoma Multiforme Studies:
1. SarCNU in Treating Patients With Recurrent Malignant Glioma

2. Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma

3. Celecoxib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Who Are Receiving Anticonvulsant Drugs and Undergoing Radiation Therapy

4. Radiolabeled Monoclonal Antibody in Treating Patients With Glioblastoma Multiforme or Anaplastic Astrocytoma

5. Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma

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