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Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone 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 Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma Clinical research trials and Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone 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 Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma. Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone 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 Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma clinical trial. Subjects typically recieve the finest healthcare available for their Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone 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 > "I" Clinical Trials Conditions > Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma  Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma
Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma
For Condition: childhood rhabdomyosarcoma,Ewing's family of tumors,Osteosarcoma,childhood soft tissue sarcoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic or unresectable locally advanced soft tissue sarcoma or bone sarcoma.
Details: OBJECTIVES: - Determine the efficacy of imatinib mesylate, as measured by response rate, in patients with metastatic or unresectable locally advanced soft tissue or bone sarcoma who have failed one or more prior treatment regimens. - Determine the clinical and laboratory toxic effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to disease subtype. Patients receive oral imatinib mesylate twice daily. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 60-120 patients (6-12 per stratum) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 10 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed metastatic or unresectable locally advanced (stage IV or recurrent) soft tissue or bone sarcoma - Eligible subtypes: - Ewing's family (e.g., primitive neuroectodermal tumor) - Osteosarcoma - Synovial sarcoma - Rhabdomyosarcoma (e.g., alveolar, embryonal, or pleomorphic) - Liposarcoma (all variants) - Malignant fibrous histiocytoma - Peripheral nerve sheath (e.g., malignant peripheral nerve sheath tumor, neurofibrosarcoma, or schwannoma) - Fibrosarcoma - Angiosarcoma (all variants) - Failed standard therapy with no available salvage regimens - Unidimensionally measurable target lesions by x-ray, CT scan, MRI, PET, or physical examination - Must be outside prior irradiation fields or have documented disease progression at least 6 weeks after completion of prior radiotherapy PATIENT CHARACTERISTICS: Age: - 10 and over Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 3 times upper limit of normal (ULN) - ALT and AST less than 2.5 times ULN Renal: - Creatinine less than 1.5 times ULN Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for at least 1 week after study participation for female patients and for at least 3 months after study participation for male patients PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - No hormonal birth control Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered Surgery: - Not specified Other: - At least 28 days since any prior systemic therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeeHelman, Study Chair, Pediatric Oncology Branch
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York City, New York, 10032
United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021-6007
United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Additional Information:
Study ID Numbers: CDR0000069239; CCUM-2001-034,NCI-02-C-0097,CPMC-IRB-14060
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031915
Other Childhood Soft Tissue Sarcoma Studies:
1. Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma
2. Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors
3. A Pilot Study for the Treatment of Patients with Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors
4. Temozolomide and O6-Benzylguanine for Treating Childhood Cancers
5. Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
Related Studies:
Other childhood soft tissue sarcoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma
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