PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA
carmustine
+ conventional surgery
Brain Diseases+18
+ Central Nervous System Diseases
+ Neoplasms
Treatment Study
Summary
Study start date: September 1, 1996
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesOpen University of Alabama at Birmingham Comprehensive Cancer Center in Google MapsH. Lee Moffitt Cancer Center and Research Institute
Tampa, United StatesEmory University Hospital - Atlanta
Atlanta, United StatesSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, United States