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Irinotecan Plus Carmustine in Treating Patients With Recurrent Primary Malignant Glioma



Irinotecan Plus Carmustine in Treating Patients With Recurrent Primary Malignant Glioma

For Condition: recurrent adult brain tumor
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Duke University
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus carmustine in treating patients who have recurrent primary malignant glioma.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan administered in combination with a fixed dose of carmustine in patients with recurrent primary malignant glioma. II. Determine the toxic effects of irinotecan and carmustine in these patients. PROTOCOL OUTLINE: This is a dose escalation study of irinotecan. Patients receive irinotecan IV over 90 minutes weekly on weeks 1-4 and carmustine IV over 1 hour on weeks 1-6. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities. PROJECTED ACCRUAL: Approximately 18-36 patients 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 proven recurrent primary malignant glioma; Measurable recurrent or residual primary central nervous system neoplasm confirmed by MRI --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 6 weeks since prior chemotherapy; No prior irinotecan or carmustine treatment failure; No more than 1 prior chemotherapy regimen - Endocrine therapy: Patients taking corticosteroids must be on a stable dose for at least 1 week prior to study and the dose should not escalate over entry dose level - Radiotherapy: At least 6 weeks since prior radiotherapy - Surgery: At least 3 weeks since prior surgical resection - Other: No concurrent medication that may interfere with study results --Patient Characteristics-- - Age: 18 and over - Performance Status: Karnofsky 60-100% - Hematopoietic: Hematocrit greater than 29%; Absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 125,000/mm3 - Hepatic: SGOT less than 1.5 times upper limit of normal (ULN); Bilirubin less than 1.5 times ULN - Renal: Creatinine less than 1.5 mg/dL; BUN less than 25 mg/dL - Pulmonary: DLCO at least 60% - Other: Not pregnant; Fertile patients must use effective contraception
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
HenryFriedman,  Study Chair,  Duke University

Duke Comprehensive Cancer Center
Durham,  North Carolina,  27710
United States
 


Additional Information:
Study ID Numbers:  CDR0000065523;  DUMC-000564-00-3R3,NCI-G97-1243,DUMC-0509-99-3R2,DUMC-0509-99-4R1,DUMC-427-98-3R1,DUMC-461-97-3
Study Start Date: April 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002988

Other Recurrent Adult Brain Tumor Studies:
1. Neoadjuvant and Adjuvant Fenretinide Compared With Adjuvant Fenretinide Alone in Treating Patients Who Are Undergoing Surgical Resection For Recurrent Glioblastoma Multiforme

2. Irinotecan Plus Carmustine in Treating Patients With Recurrent Primary Malignant Glioma

3. PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas

4. Temozolomide in Treating Patients With Anaplastic Oligodendroglioma

5. Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

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Irinotecan Plus Carmustine in Treating Patients With Recurrent Primary Malignant Glioma
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