Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

December 12, 2007

Primary Completion Date

December 1, 2010

Study Completion Date

December 1, 2010

Conditions
Metastatic Brain Cancer
Interventions
DRUG

GLIADEL

Resect the tumor as completely as possible. After repeated irrigation of the decompressed area demonstrates no bleeding, and care is taken not to have any foreign material enter the ventricle, up to 8 GLIADEL wafers should be placed to cover the entire surface area of the resection cavity (if possible). Slight overlapping of wafer edges is permitted. The number of wafers will be determined by the size of the tumor resection cavity. Each GLIADEL wafer contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when 8 wafers are implanted. The GLIADEL wafer is a round white to yellow disk with flat surfaces.

Trial Locations (17)

10021

Weill Medical College Department of Neurological Surgery, New York

19140

Temple University, Philadelphia

27599

University of North Carolina, Chapel Hill

28204

Carolina Neurosurgery & Spine Associates, Charlotte

33606

University of South Florida, Tampa

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

37232

Vanderbilt University Medical Center, Nashville

38104

Methodist University Hospital, Memphis

43210

The Ohio State University Medical Center, Columbus

44195

Cleveland Clinic, Cleveland

52242

University of Iowa Hospitals and Clinics, Iowa City

60201

NorthShore University HealthSystem Reseach Institute, Evanston

60637

The University of Chicago, Chicago

75390

UT Southwestern Medical Center at Dallas, Dallas

75702

Trinity Mother Frances Health System, Tyler

85724

University of Arizona / University Medical Center, Tucson

90095

University of California, Los Angeles, Los Angeles

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT00525590 - Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer | Biotech Hunter | Biotech Hunter