Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers
carmustine
+ polifeprosan 20 with carmustine implant
+ surgical procedure
Brain Diseases+14
+ Central Nervous System Diseases
+ Neoplasms
Treatment Study
Summary
Study start date: January 1, 1998
Actual date on which the first participant was enrolled.OBJECTIVES: Determine the antitumor activity of Gliadel wafers (carmustine) in the treatment of recurrent supratentorial low grade glioma. Assess the toxicity of this therapy in these patients. OUTLINE: Patients are stratified by disease (fibrillary astrocytoma vs oligodendroglioma or mixed glioma). Patients receive up to 8 Gliadel wafers (containing carmustine) implanted in the resected tumor cavity. Patients are followed every 2 months. PROJECTED ACCRUAL: This study will accrue a maximum of 68 patients within 18-24 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.68 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.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: Histologically confirmed recurrent primary low grade glioma including: Fibrillary astrocytoma Oligodendroglioma Mixed glioma Evidence of measurable enhancing or non-enhancing CNS neoplasm on MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Hematocrit greater than 29% Absolute neutrophil count greater than 1500/mm^3 Platelet count greater than 125,000/mm^3 Hepatic: SGOT less than 1.5 times upper limit of normal (ULN) Bilirubin less than 1.5 times ULN Renal: Creatinine less than 1.5 mg/dL BUN less than 25 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy unless disease progression Endocrine therapy: Concurrent corticosteroids allowed (must be on stable dose for 1 week prior to study) No concurrent immunosuppressive agents Radiotherapy: At least 4 weeks since prior radiotherapy unless disease progression Surgery: Not specified Other: No other concurrent medication that may interfere with 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 1 location
Duke Comprehensive Cancer Center
Durham, United StatesOpen Duke Comprehensive Cancer Center in Google Maps