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Irinotecan Plus Carmustine in Treating Patients With Recurrent Primary Malignant Glioma

This study has been completed.
Information provided by (Responsible Party):
Duke University Identifier:
First received: November 1, 1999
Last updated: June 19, 2013
Last verified: February 2013

November 1, 1999
June 19, 2013
April 1997
November 2000   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00002988 on Archive Site
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Irinotecan Plus Carmustine in Treating Patients With Recurrent Primary Malignant Glioma
Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC #6616348) Plus BCNU (NSC #409962)

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.

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.

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.

Phase 1
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: carmustine
  • Drug: irinotecan hydrochloride
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2000
November 2000   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically proven recurrent primary malignant glioma Measurable recurrent or residual primary central nervous system neoplasm confirmed by MRI

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

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

18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
0564, DUMC-000564-00-3R3, DUMC-0509-99-3R2, DUMC-0509-99-4R1, DUMC-427-98-3R1, DUMC-461-97-3, NCI-G97-1243, CDR0000065523
Not Provided
Duke University
Duke University
National Cancer Institute (NCI)
Study Chair: Henry S. Friedman, MD Duke Cancer Institute
Duke University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP