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Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma Clinical research trials and Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma. Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma clinical trial. Subjects frequently get the best healthcare possible for their Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma  Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma
Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma
For Condition: Mixed Gliomas,adult ependymoma,adult glioblastoma multiforme,adult anaplastic astrocytoma,adult anaplastic oligodendroglioma
Status: No longer recruiting
Sponsor(s): Memorial Sloan-Kettering 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. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy following radiation therapy in treating patients who have malignant glioma.
Details: OBJECTIVES: - Determine the safety and efficacy of extended low-dose temozolomide when combined with carmustine after radiotherapy in patients with malignant glioma. - Determine the maximum tolerated dose of this combination in this patient population. - Determine time to progression as measured from baseline gadolinium-enhanced magnetic resonance imaging in patients treated with this regimen. OUTLINE: This is a dose-escalation study of temozolomide. Patients receive oral temozolomide once daily on days 1-28 and carmustine IV over 1-3 hours beginning within 72 hours after starting temozolomide. Courses repeat every 8 weeks for up to 1 year in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1-2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignant glioma - Glioblastoma - Gliosarcoma - High-grade glioma - Anaplastic astrocytoma - Anaplastic mixed oligoastrocytoma - Anaplastic oligodendroglioma - Anaplastic ependymoma - Must have completed radiotherapy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - More than 3 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - SGOT/SGPT less than 3 times ULN - Alkaline phosphatase less than 2 times ULN Renal: - BUN less than 1.5 times ULN - Creatinine less than 1.5 times ULN Pulmonary: - Pulmonary function test with diffusion greater than 50 OR - Clearance by the pulmonary service Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No AIDS-related illness - No nonmalignant systemic disease that would preclude study - No acute infection requiring IV antibiotics - No psychiatric condition that would preclude study compliance - No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) - No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy - No prior biologic therapy Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 2 weeks since prior radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeffreyRaizer, 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: CDR0000067793; MSKCC-99114,NCI-G00-1765
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005637
Other Adult Anaplastic Astrocytoma Studies:
1. Carmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma
2. Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain
3. Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma
4. Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
5. Taurolidine in Treating Patients With Recurrent or Progressive Glioma
Related Studies:
Other adult anaplastic astrocytoma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma
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