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Home > "C" Clinical Trials Conditions > Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma  Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
For Condition: adult well-differentiated oligodendroglioma,adult brain stem glioma,adult well-differentiated mildly and moderately anaplastic astrocytoma,recurrent adult brain tumor,adult noninfiltrating astrocytoma,Mixed Gliomas
Status: No longer recruiting
Sponsor(s): Duke Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HenryFriedman, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000066503; DUMC-1706-02-9R5,DUMC-1706-01-9R4,DUMC-000693-00-4,DUMC-1509-97-10,DUMC-1568-98-10R1,DUMC-1706-00-9R3,DUMC-97131,NCI-G98-1470
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003467
Other Mixed Gliomas Studies:
1. Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma
2. Fenretinide in Treating Patients With Recurrent Malignant Glioma
3. Temozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Anaplastic Glioma
4. Carmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma
5. Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
Related Studies:
Other Mixed Gliomas Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
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