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| Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00112463 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with metastatic or unresectable soft tissue sarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumor Sarcoma |
Drug: romidepsin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of Single Agent Depsipeptide (FK228) in Metastatic or Unresectable Soft Tissue Sarcomas |
| Estimated Enrollment: | 36 |
| Study Start Date: | January 2005 |
| Estimated Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
After completion of study treatment, patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within approximately 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed soft tissue sarcoma (STS), including, but not limited to, the following histologies:
Gastrointestinal stromal tumors (GIST)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No cardiac arrhythmia requiring anti-arrhythmic medication
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 1 prior chemotherapy regimen for sarcoma
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Arizona | |
| CCOP - Western Regional, Arizona | |
| Phoenix, Arizona, United States, 85006-2726 | |
| United States, California | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609-3305 | |
| United States, Georgia | |
| Harbin Clinic Cancer Services | |
| Rome, Georgia, United States, 30165 | |
| United States, Illinois | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| United States, North Carolina | |
| High Point Regional Hospital | |
| High Point, North Carolina, United States, 27261 | |
| Brody School of Medicine at East Carolina University | |
| Greenville, North Carolina, United States, 27858 | |
| CCOP - Southeast Cancer Control Consortium | |
| Goldsboro, North Carolina, United States, 27534-9479 | |
| Alamance Cancer Center at Alamance Regional Medical Center | |
| Burlington, North Carolina, United States, 27216 | |
| Hugh Chatham Memorial Hospital | |
| Elkin, North Carolina, United States, 28621 | |
| Southeastern Medical Oncology Center - Goldsboro | |
| Goldsboro, North Carolina, United States, 27534 | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| United States, Ohio | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43215 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Virginia | |
| Cancer Center of the Piedmont | |
| Danville, Virginia, United States, 24541 | |
| Danville Hematology and Oncology, Incorporated | |
| Danville, Virginia, United States, 24541 | |
| Study Chair: | Paul D. Savage, MD | Wake Forest University |
More Information
| Responsible Party: | California Cancer Consortium ( Edward Newman ) |
| Study ID Numbers: | CDR0000433042, CCCWFU-71103 |
| Study First Received: | June 2, 2005 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00112463 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent adult soft tissue sarcoma stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma gastrointestinal stromal tumor adult alveolar soft-part sarcoma adult angiosarcoma adult epithelioid sarcoma adult extraskeletal chondrosarcoma adult extraskeletal osteosarcoma adult fibrosarcoma |
adult leiomyosarcoma adult liposarcoma adult malignant fibrous histiocytoma adult malignant hemangiopericytoma adult malignant mesenchymoma adult neurofibrosarcoma adult rhabdomyosarcoma adult synovial sarcoma metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor |
|
Histiocytoma, Malignant Fibrous Fibrosarcoma Neuroectodermal Tumors, Primitive Leiomyosarcoma Histiocytoma, Benign Fibrous Gastrointestinal Diseases Malignant Fibrous Histiocytoma Sarcoma, Synovial Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Sarcoma, Ewing's Epithelioid Sarcoma Chondrosarcoma Osteogenic Sarcoma |
Neuroepithelioma Synovial Sarcoma Sarcoma, Alveolar Soft Part Ewing's Family of Tumors Alveolar Soft Part Sarcoma Rhabdomyosarcoma Digestive System Neoplasms Romidepsin Osteosarcoma Hemangiosarcoma Ewing's Sarcoma Hemangiopericytoma Recurrence Neuroectodermal Tumors Malignant Mesenchymal Tumor |
|
Digestive System Neoplasms Neoplasms by Histologic Type Gastrointestinal Diseases Antineoplastic Agents Romidepsin Antibiotics, Antineoplastic Pharmacologic Actions Neoplasms, Connective and Soft Tissue |
Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Sarcoma Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |