Carmustine in Treating Patients With Recurrent Malignant Glioma

February 6, 2009 updated by: National Cancer Institute (NCI)

PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA

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 carmustine in treating patients who are undergoing surgery for recurrent malignant glioma.

Study Overview

Status

Completed

Conditions

Brain and Central Nervous System Tumors

Intervention / Treatment

Detailed Description

OBJECTIVES:

Determine the safety of polifeprosan 20 with carmustine implant (GLIADEL) in patients undergoing surgery for recurrent malignant glioma.

OUTLINE: This is a dose escalation study.

All patients undergo maximal tumor resection. At the time of surgery, groups of 6 patients receive up to 8 polifeprosan 20 wafers containing increasing doses of carmustine implanted into the resection cavity.

Patients with an intraoperative diagnosis other than glioblastoma multiforme or anaplastic astrocytoma do not receive wafer implantation, and are removed from study.

Patients are followed 3, 6, and 12 months after implantation.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.

Study Type

Interventional

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35294-3295
    - University of Alabama at Birmingham Comprehensive Cancer Center
- Florida
  - Tampa, Florida, United States, 33612-9497
    - H. Lee Moffitt Cancer Center and Research Institute
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Emory University Hospital - Atlanta
- Maryland
  - Baltimore, Maryland, United States, 21231-2410
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital Cancer Center
- Michigan
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
- North Carolina
  - Winston-Salem, North Carolina, United States, 27157-1082
    - Comprehensive Cancer Center at Wake Forest University
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104-4283
    - University of Pennsylvania Cancer Center
- Texas
  - San Antonio, Texas, United States, 78284-7811
    - University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Pathologically confirmed recurrent malignant glioma for which surgery is indicated
Unilateral, supratentorial, solitary lesion at least 1.0 cm in diameter on contrast-enhanced CT or MRI

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 60-100%

Life expectancy:

At least 8 weeks

Hematopoietic:

WBC at least 3,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin, AST, ALT, and alkaline phosphatase less than 2.5 times normal

Renal:

Creatinine less than 1.5 times normal
BUN less than 2.5 times normal
Protein no greater than 3 g/dL
No gross hematuria

Other:

No hypersensitivity to nitrosoureas
Not pregnant
Fertile patients must use effective contraception
No concurrent life threatening disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent immunotherapy during first 8 weeks of study

Chemotherapy:

At least 4 weeks since chemotherapy (6 weeks since nitrosoureas)
No concurrent chemotherapy during first 8 weeks of study

Endocrine therapy:

Not specified

Radiotherapy:

Prior definitive external-beam radiotherapy (i.e., at least 5,000 cGy) required
No concurrent radiotherapy or brachytherapy during first 4 weeks of study

Surgery:

Prior cytoreductive surgery for supratentorial brain tumor required
Biopsy alone not sufficient

Other:

No concurrent investigational therapy during first 8 weeks of study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

Study Chair: Alessandro Olivi, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Olivi A, Grossman SA, Tatter S, Barker F, Judy K, Olsen J, Bruce J, Hilt D, Fisher J, Piantadosi S; New Approaches to Brain Tumor Therapy CNS Consortium. Dose escalation of carmustine in surgically implanted polymers in patients with recurrent malignant glioma: a New Approaches to Brain Tumor Therapy CNS Consortium trial. J Clin Oncol. 2003 May 1;21(9):1845-9. doi: 10.1200/JCO.2003.09.041.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1996

Study Registration Dates

First Submitted

December 10, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

February 9, 2009

Last Update Submitted That Met QC Criteria

February 6, 2009

Last Verified

January 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000065129
NABTT-101-9601
JHOC-NABTT-101-9601
NCI-T96-0052H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.