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Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma Clinical research trials and Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma. Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma clinical trial. Participants frequently obtain the most expert healthcare available for their Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma  Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma
Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma
For Condition: uterine sarcoma,uterine leiomyosarcoma,adult soft tissue sarcoma
Status: Recruiting
Sponsor(s): Herbert Irving Comprehensive 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. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide with thalidomide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with thalidomide in treating patients who have metastatic, locally advanced, or unresectableleiomyosarcoma.
Details: OBJECTIVES: - Determine the efficacy of temozolomide and thalidomide in patients with metastatic, locally advanced, or unresectable leiomyosarcoma. - Determine the time to progression in patients treated with this regimen. - Determine the overall survival of patients treated with this regimen. - Determine the clinical and laboratory toxic effects and tolerability of this regimen in these patients. OUTLINE: Patients receive oral temozolomide once daily for 7 days every other week and oral thalidomide once daily. Treatment continues for up to 26 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 7.5-25 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed leiomyosarcoma - Metastatic, locally advanced, or unresectable - Ineligible for other high priority national or institutional study - At least 1 unidimensionally measurable lesion documented on radiologic study - At least 2 cm by 2 cm - Not previously irradiated unless disease progression at the site is evident - No brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - SWOG 0-2 Life expectancy: - More than 2 months Hematopoietic: - WBC greater than 3,000/mm^3 - Neutrophil count at least 1,500/mm^3 - Platelet count greater than 70,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - Bilirubin less than upper limit of normal (ULN) - SGOT or SGPT less than 1.5 times ULN* - Alkaline phosphatase less than 2 times ULN* NOTE: * Less than 5 times ULN if documented liver disease Renal: - Creatinine less than 1.5 times normal OR - Creatinine clearance greater than 60 mL/min - BUN less than 1.5 times normal Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 2 forms of effective contraception for 4 weeks before, during, and for 4 weeks after study therapy - No acute infection requiring systemic antibiotics - No frequent vomiting or medical condition that would preclude intake of oral medication (e.g., partial bowel obstruction) - No other serious medical or psychiatric illness that would preclude study participation - No prior malignancy except curatively treated carcinoma in situ of the cervix or skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 4 weeks since prior chemotherapy - No more than 3 prior systemic chemotherapy regimens for metastatic, locally advanced, or unresectable leiomyosarcoma - Prior dacarbazine allowed Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy - No prior radiotherapy to 50% or more of bone marrow - Concurrent radiotherapy for local control or palliative therapy for painful bony or soft tissue lesion allowed Surgery: - At least 4 weeks since prior surgery and recovered Other: - Recovered from all prior therapies - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertTaub, Study Chair, Columbia University
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Mary Keohan 212-305-0592
Additional Information:
Study ID Numbers: CDR0000069314; NCI-G02-2060,CPMC-IRB-14323
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033709
Other Adult Soft Tissue Sarcoma Studies:
1. Combination Chemotherapy With or Without Hyperthermia Therapy in Treating Patients With Soft Tissue Sarcoma
2. Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma
3. Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
4. Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma
5. Liposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
Related Studies:
Other adult soft tissue sarcoma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma
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