Brain and Central Nervous System Tumors Clinical Trial
Official title:
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.
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.
;
Primary Purpose: Treatment
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