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| Descriptive Information Fields | |||||
| Brief Title † | FR901228 in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma | ||||
| Official Title † | A Phase II Study of Single Agent Depsipeptide (FK228) in Metastatic or Unresectable Soft Tissue Sarcomas | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Objective tumor response (complete and partial) [ Designated as safety issue: No ] Toxicity [ Designated as safety issue: Yes ] Time to progression [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Gastrointestinal Stromal Tumor Sarcoma |
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| Intervention † | Drug: romidepsin | ||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 36 | ||||
| Start Date † | January 2005 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00112463 | ||||
| Organization ID | CDR0000433042 | ||||
| Secondary IDs †† | CCCWFU-71103 | ||||
| Study Sponsor † | Wake Forest University | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | June 2, 2005 | ||||
| Last Updated Date | July 23, 2008 | ||||