Irinotecan Plus Carmustine in Treating Patients With Recurrent Primary Malignant Glioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00002988
First received: November 1, 1999
Last updated: June 19, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Brain and Central Nervous System Tumors
Drug: carmustine
Drug: irinotecan hydrochloride
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC #6616348) Plus BCNU (NSC #409962)

Resource links provided by NLM:


Further study details as provided by Duke University:

Estimated Enrollment: 36
Study Start Date: April 1997
Study Completion Date: November 2000
Primary Completion Date: November 2000 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002988

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Henry S. Friedman, MD Duke Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00002988     History of Changes
Other Study ID Numbers: 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
Study First Received: November 1, 1999
Last Updated: June 19, 2013
Health Authority: United States: Federal Government
United States: Instituational Review Board

Keywords provided by Duke University:
recurrent adult brain tumor

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Glioma
Neoplasms by Site
Neoplasms
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Carmustine
Irinotecan
Camptothecin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014