Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Durham, North Carolina 27710


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma.


Study summary:

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.


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


NCT ID:

NCT00003467


Primary Contact:

Study Chair
Henry S. Friedman, MD
Duke University


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 25, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.