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Home > "T" Clinical Trials Conditions > Temozolomide in Treating Patients With Recurrent Malignant Glioma  Temozolomide in Treating Patients With Recurrent Malignant Glioma
Temozolomide in Treating Patients With Recurrent Malignant Glioma
For Condition: adult anaplastic oligodendroglioma,recurrent adult brain tumor,Mixed Gliomas,adult anaplastic astrocytoma,adult glioblastoma multiforme,Quality of Life
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
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 temozolomide in treating patients who have recurrent malignant glioma.
Details: OBJECTIVES: I. Determine the safety and efficacy of temozolomide in patients with recurrent malignant glioma. II. Determine the radiographic response to this regimen in these patients. III. Determine the time to tumor progression of these patients on this regimen. IV. Determine the quality of life of these patients. PROTOCOL OUTLINE: Patients receive oral temozolomide once daily for 42 days. Courses repeat every 70 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed every 1-2 months. Patients are followed every 3-4 months. PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed recurrent malignant glioma, including: Glioblastoma; Gliosarcoma; High grade glioma; Anaplastic astrocytoma; Anaplastic mixed oligoastrocytoma; Anaplastic oligodendroglioma - Must have evidence of tumor recurrence or progression on gadolinium enhanced MRI or CT scan following radiotherapy with or without chemotherapy --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior immunotherapy; At least 4 weeks since prior biologic therapy - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy; No prior temozolomide or dacarbazine - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; At least 4 weeks since prior external beam radiotherapy; At least 8 weeks since prior stereotactic radiosurgery - Surgery: At least 2 weeks since prior brain biopsy, craniotomy, or other surgery --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL - Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN); SGOT and SGPT less than 3 times ULN; Alkaline phosphatase less than 2 times ULN - Renal: Creatinine less than 1.5 times ULN; BUN less than 1.5 times ULN - Other: No nonmalignant systemic disease that would cause patient to be a poor medical risk; No acute infection requiring intravenous antibiotics; No psychological disorder that would interfere with study compliance; HIV negative; No AIDS-related illness; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction); No prior or concurrent malignancy, except: Surgically cured carcinoma in situ of the cervix; Basal or squamous cell skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LaurenAbrey, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067337; MSKCC-IRB-99019,NCI-G99-1602
Study Start Date: June 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004113
Other Adult Glioblastoma Multiforme Studies:
1. Carmustine in Treating Patients With Recurrent Malignant Glioma
2. High-Dose Methotrexate and Leucovorin Followed By Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
3. Combination Chemotherapy in Treating Patients With Recurrent Glioblastoma Multiforme
4. Celecoxib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Who Are Receiving Anticonvulsant Drugs and Undergoing Radiation Therapy
5. Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Temozolomide in Treating Patients With Recurrent Malignant Glioma
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