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Irinotecan Plus Carmustine in Treating Patients With Recurrent Primary Malignant Glioma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Duke University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002988
  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 I

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Carmustine    Irinotecan    Irinotecan hydrochloride   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   36
Study Start Date:   April 1997

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

Investigators
Study Chair:     Henry S. Friedman, MD     Duke University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000065523, DUMC-000564-00-3R3, DUMC-0509-99-3R2, DUMC-0509-99-4R1, DUMC-427-98-3R1, DUMC-461-97-3, NCI-G97-1243
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002988
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor  

Study placed in the following topic categories:
Neuroectodermal Tumors
Brain Neoplasms
Neoplasms, Germ Cell and Embryonal
Irinotecan
Carmustine
Neuroepithelioma
Glioma
Central Nervous System Neoplasms
Camptothecin
Recurrence
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nervous System Diseases
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on September 16, 2008




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