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.

Condition	Treatment or Intervention	Phase
recurrent adult brain tumor	Drug: carmustine  Drug: irinotecan	Phase I

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

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

Study chairs or principal investigators

Henry S. Friedman,  Study Chair,  Duke University   

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
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002988
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08