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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
Other Uterine Sarcoma Studies:
1. Biomarkers of Benzene Exposure in Inner City Residents
2. Pesticides--Health Fertility and Reproductive Risk
3. STI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma
4. Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients
5. Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
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Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma
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