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Home > "T" Clinical Trials Conditions > Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma  Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma
Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma
For Condition: adult glioblastoma multiforme,adult anaplastic astrocytoma,recurrent adult brain tumor,Mixed Gliomas
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North American Brain Tumor Consortium
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of temozolomide and carmustine in treating patients with anaplastic glioma.
Details: OBJECTIVES: I. Evaluate the activity, measured in terms of progression free survival, of carmustine plus temozolomide in recurrent glioblastoma. II. Estimate the response rate of recurrent glioblastomas to this combination. III. Estimate the response rate of newly diagnosed anaplastic astrocytomas and mixed anaplastic glioma to this combination. IV. Evaluate the qualitative and quantitative toxicities of this combination in patients with anaplastic gliomas. PROTOCOL OUTLINE: This is a nonrandomized study. Patients are stratified by disease (recurrent glioblastoma vs anaplastic astrocytoma or mixed anaplastic glioma). Patients receive carmustine intravenously on day 1 two hours prior to temozolomide. Temozolomide is administered orally on day 1. Cycles repeat every 42 days. Treatment for patients with recurrent glioblastoma may continue for 8 cycles in the absence of disease progression or unacceptable toxicity. If there is no disease progression after 8 cycles, treatment may continue further at the investigator's discretion. Patients with anaplastic astrocytoma or mixed anaplastic glioma continue for 4 cycles of treatment. Patients are followed periodically at the investigator's discretion, at least twice in the first 4 months, and then until death. PROJECTED ACCRUAL: A minimum of 17 patients and a maximum of 37 patients will be accrued in the recurrent glioblastoma stratum and 45 patients will be accrued into the anaplastic astrocytoma and mixed anaplastic glioma stratum.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed malignant glioma - Recurrent glioblastoma - Anaplastic astrocytoma - Mixed anaplastic glioma - For recurrent glioblastoma: Required documented progression must include an increase in tumor size of at least 25% or appearance of new lesion - For anaplastic astrocytoma or mixed anaplastic glioma: Must have measurable, contrast enhancing disease on postoperative CT or MRI scan; No postoperative radiation or chemotherapy - If patients have received prior brachytherapy or stereotactic radiosurgery, they must have confirmation of true progressive disease rather than radiation necrosis by PET scanning or biopsy --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent biologic therapy - Chemotherapy: No prior nitrosourea or temozolomide; No more than 1 prior chemotherapy regimen allowed for patients with glioblastoma; At least 6 weeks since mitomycin or procarbazine and recovered; At least 4 weeks since other prior chemotherapy and recovered; No other concurrent chemotherapy - Endocrine therapy: If receiving steroids, must be on a stable steroid dose for at least 72 hours prior to study; No other concurrent endocrine therapy - Radiotherapy: At least 6 weeks since radiotherapy; No greater than 10-20% of marrow irradiated in prior radiotherapy; No other concurrent radiotherapy - Surgery: Surgery allowed --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: WBC at least 3,500/mm3; Absolute neutrophil count at least 1,800/mm3; Platelet count at least 125,000/mm3; Hemoglobin at least 9 g/dL (transfusion allowed) - Hepatic: Bilirubin less than 1.5 mg/dL; SGOT less than 2.0 times upper limit of normal - Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 70 mL/min - Cardiovascular: No uncontrolled arrhythmias or conduction defects; No unstable or newly diagnosed angina pectoris; No New York Heart Association class II-IV heart disease; No congestive heart failure; No major problems with edema (e.g., severe Cushing's syndrome, residual leg swelling from deep-vein thrombosis); No recent coronary artery disease; No poorly controlled hypertension (diastolic greater than 110 mmHg and systolic greater than 180 mmHg) - Pulmonary: DLCO greater than 80% of expected value - Other: HIV negative; No major psychiatric illness; No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been free of disease for 5 years; Not pregnant or nursing; Adequate contraception required of all fertile patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelPrados, Study Chair, North American Brain Tumor Consortium
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Additional Information:
Study ID Numbers: CDR0000065986; NABTC-9701,NCI-T96-0082
Study Start Date: January 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003176
Other Adult Glioblastoma Multiforme Studies:
1. Imatinib Mesylate in Treating Patients With Gliomas
2. Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas
3. Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma
4. Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma
5. Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma
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