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| Sponsor: | Wake Forest University |
|---|---|
| Collaborator: |
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 |
|
Neoplasms by Histologic Type Digestive System Neoplasms Neuroectodermal Tumors, Primitive Antineoplastic Agents Gastrointestinal Diseases Neoplasms, Nerve Tissue Romidepsin Antibiotics, Antineoplastic Pharmacologic Actions Neoplasms, Connective and Soft Tissue Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Neoplasms, Germ Cell and Embryonal Sarcoma Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |