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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00087074 |
RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well CCI-779 works in treating patients with soft tissue sarcoma or gastrointestinal stromal tumor.
Condition | Intervention | Phase |
---|---|---|
Gastrointestinal Stromal Tumor Sarcoma |
Drug: temsirolimus |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Trial Of CCI-779 In Patients With Soft Tissue Sarcoma |
Study Start Date: | June 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study within 4-10 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically and cytologically confirmed diagnosis of 1 of the following:
Measurable disease
No known brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Arizona | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259 | |
United States, District of Columbia | |
Howard University Cancer Center at Howard University Hospital | |
Washington, District of Columbia, United States, 20060 | |
United States, Florida | |
Mayo Clinic - Jacksonville | |
Jacksonville, Florida, United States, 32224 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital | |
Saint Louis, Missouri, United States, 63110 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 |
Study Chair: | Scott Okuno, MD | Mayo Clinic |
Study ID Numbers: | CDR0000372912, MAYO-MC027B, NCI-6156 |
Study First Received: | July 8, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00087074 |
Health Authority: | United States: Federal Government |
recurrent adult soft tissue sarcoma stage I adult soft tissue sarcoma stage II adult soft tissue sarcoma |
stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma gastrointestinal stromal tumor |
Neoplasms, Connective and Soft Tissue Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Malignant mesenchymal tumor |
Sarcoma Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Soft tissue sarcomas Recurrence |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site |