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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 qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about 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 health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including 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 obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma clinical trial. Test subjects typically receive 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, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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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 Uterine Sarcoma Studies:
1. STI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma
2. Vincristine, Dactinomycin, Cyclophosphamide, and Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
3. Doxorubicin With or Without Ifosfamide in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
4. Combination Chemotherapy With or Without Hyperthermia Therapy 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 uterine 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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