|
||||||||||||||||||||||
|
|
Phase II Study of Polifeprosan 20 With Carmustine Implant (Gliadel Wafer®) and O6-Benzylguanine in Patients With Recurrent Glioblastoma Multiforme
Alternate Title Gliadel Wafer and O6-Benzylguanine in Treating Patients With Recurrent Glioblastoma Multiforme
Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy:
[Note: * Unless there is unequivocal evidence of tumor progression] Patient Characteristics:
Expected Enrollment 50A total of 50 patients will be accrued for this study. Outcomes Primary Outcome(s)Activity of polifeprosan 20 with carmustine implant (Gliadel wafer) in combination with O6-benzylguanine Outline This is an open-label study. Patients undergo surgical resection of tumor followed by placement of polifeprosan 20 with carmustine implant (Gliadel wafer®) . Within 6 hours after surgery, patients receive high-dose O6-benzylguanine IV over 1 hour on days 1, 3, and 5 and low-dose O6-benzylguanine IV continuously on days 1-5. After completion of study treatment, patients are followed every 8 weeks. Trial Lead Organizations Duke Comprehensive Cancer Center
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
NCI Home |
Images Version |
Contact Us |
Policies |
Accessibility |
Viewing Files |
FOIA |
Site Help |
Site Map
|
A Service of the National Cancer Institute |