|
Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma Clinical research trials and Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma. Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma clinical trial. Test subjects typically receive the most effective healthcare possible for their Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma  Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
For Condition: adult anaplastic oligodendroglioma,recurrent adult brain tumor,adult anaplastic astrocytoma
Status: No longer recruiting
Sponsor(s): Herbert Irving Comprehensive 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 or progressive malignant glioma.
Details: OBJECTIVES: I. Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide. II. Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide. III. Determine the toxicity of this regimen in these patients. PROTOCOL OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme (closed to accrual 11/30/01) vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma). Patients receive oral temozolomide twice daily for 5 consecutive days. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven recurrent or progressive malignant glioma of the following types: - Anaplastic oligodendroglioma or oligoastrocytoma OR - Anaplastic astrocytoma OR - Glioblastoma multiforme (stratum closed to accrual 11/30/01) Patients who have failed radiotherapy are eligible Measurable disease by CT or MRI scan --Prior/Concurrent Therapy-- Biologic therapy: No concurrent epoetin alfa Chemotherapy: At least 6 weeks since other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: - See Disease Characteristics - At least 3 months since prior radiotherapy (exceptions allowed for recurrent/progressive disease at discretion of primary investigator) Surgery: Recovered from prior surgery Other: - No other concurrent investigational agents - Concurrent anticonvulsant therapy allowed --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: - Absolute neutrophil count greater than 1,500/mm3 - Platelet count greater than 100,000/mm3 - Hemoglobin greater than 10 g/dL Hepatic: - SGOT or SGPT less than 3 times upper limit of normal (ULN) - Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma glutanyl transferase test must be performed) Renal: - BUN less than 1.5 times ULN - Creatinine less than 1.5 times ULN Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception - No other serious concurrent infection or other medical illness that would preclude study - No frequent vomiting or partial bowel obstruction - HIV negative - No AIDS-related illness - No other concurrent malignancy except carcinoma in situ of the cervix or basal cell skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CasildaBalmaceda, Study Chair, Herbert Irving Comprehensive Cancer Center
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Nalitt Institute for Cancer And Blood Related Diseases
Staten Island, New York, 10305
United States
Cancer Center of Albany Medical Center
Albany, New York, 12208
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Neurological Clinic
Portland, Oregon, 97210
United States
Additional Information:
Study ID Numbers: CDR0000067449; CPMC-IRB-8622,SPRI-CPMC-IRB-8622
Study Start Date: February 2000
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004204
Other Recurrent Adult Brain Tumor Studies:
1. Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma
2. Karenitecin in Treating Patients With Recurrent Malignant Glioma
3. CCI-779 in Treating Patients With Advanced Solid Tumors
4. Suramin in Treating Patients With Recurrent Primary Brain Tumors
5. Temozolomide Plus Carboplatin in Treating Patients With Recurrent Glioblastoma Multiforme
Related Studies:
Other recurrent adult brain tumor Clinical Trials
Other New York Clinical Trials
Other Albany Clinical Trials
Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
|
|
|
|
|
|
|
|
