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Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma Clinical research trials and Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma. Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma clinical trial. Subjects typically recieve the finest healthcare available for their Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma  Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma
Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma
For Condition: uterine sarcoma,adult solid tumor,musculoskeletal cancer,female reproductive cancer,adult soft tissue sarcoma,body system/site cancer,cellular diagnosis, uterine sarcoma,stage 4 adult soft tissue sarcoma,solid tumor,Cancer,cellular diagnosis, adult soft tissue sarcoma,stage, adult soft tissue sarcoma,stage, uterine sarcoma,Muscle Cancer
Status: No longer recruiting
Sponsor(s): Herbert Irving Comprehensive Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced soft tissue sarcoma.
Details: OBJECTIVES: I. Determine the efficacy, as measured by the response rate, of temozolomide in patients with unresectable, stage IV, or recurrent soft tissue sarcoma who have failed no more than 2 prior treatment regimens. II. Determine the clinical and laboratory toxicities, as well as patient tolerance, of this regimen in this patient population. PROTOCOL OUTLINE: Patients are stratified according to ECOG performance status (0-1 vs 2), prior surgery (yes vs no), prior radiotherapy (yes vs no), and prior chemotherapy regimens (0 vs 1 vs 2). Patients receive oral temozolomide every 12 hours for 5 days. Courses repeat every 4 weeks for at least 18 months in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for the first 18 months, every 6 months for the next 18 months, and then annually thereafter until death. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically, cytologically, or clinically confirmed unresectable, stage IV, or recurrent soft tissue sarcoma; No Ewing's sarcoma, Kaposi's sarcoma, bone sarcomas, mesotheliomas, or primitive neuroectodermal tumors - Bidimensionally measurable disease by x-ray, CT scan or MRI, or physical examination - No CNS metastases - No more than 2 prior chemotherapy regimens for advanced, recurrent, or metastatic disease --Prior/Concurrent Therapy-- - Biologic therapy: Prior biologic response modifier treatment allowed; At least 4 weeks since prior immunotherapy; At least 4 weeks since prior biologic therapy; No concurrent epoetin alfa - Chemotherapy: See Disease Characteristics; Prior dacarbazine allowed; At least 4 weeks since prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal therapy for malignancy - Radiotherapy: At least 3 weeks since prior radiotherapy and recovered; No prior radiotherapy to areas of measurable disease unless there is clear progression or there is measurable disease outside the area of prior radiation; No concurrent radiotherapy - Surgery: At least 4 weeks since prior surgery and recovered - Other: No other concurrent investigational drugs --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Greater than 12 weeks - Hematopoietic: Platelet count at least 100,000/mm3; Hemoglobin greater than 10.0 g/dL; WBC at least 3,500/mm3 OR Absolute neutrophil count at least 1,500/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT/SGPT no greater than 1.5 times ULN; Alkaline phosphatase less than 2 times ULN - Renal: Calcium less than ULN; Creatinine or BUN less than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or fully excised and/or treated stage I cancer currently in complete remission; No nonmalignant systemic disease rendering patient a poor medical risk; No acute infection requiring IV antibiotics HIV negative; No AIDS-related illness; No frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertTaub, Study Chair, Herbert Irving Comprehensive Cancer Center
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Additional Information:
Study ID Numbers: CDR0000066827; CPMC-IRB-8358,NCI-V98-1510
Study Start Date: September 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003718
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Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma
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