A Phase II Study of Single Agent Depsipeptide (FK228) in Metastatic or Unresectable Soft Tissue Sarcomas
PRIMARY OBJECTIVES:
I. To estimate the response rates of metastatic or unresectable soft tissue sarcomas to
single-agent depsipeptide.
II. To estimate the time to progression of metastatic or unresectable soft tissue sarcomas
to single-agent depsipeptide.
III. To evaluate the scope and extent of acute toxicities associated with single-agent
depsipeptide when given to patients with soft tissue sarcomas.
OUTLINE: This is a multicenter study.
Patients receive depsipeptide (romidepsin) intravenously (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 up every 2 months.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumor response (complete and partial)
Estimated as the proportion of partial and complete responders.
Up to 5 years
No
Paul Savage
Principal Investigator
Wake Forest University
United States: Food and Drug Administration
NCI-2012-01037
NCT01645683
January 2005
Name | Location |
---|---|
Memorial Medical Center | Springfield, Illinois 62781 |
Southeastern Medical Oncology Center | Goldsboro, North Carolina 27534 |
Wellmont Holston Valley Hospital and Medical Center | Kingsport, Tennessee 37662 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
Bay Area Tumor Institution CCOP | Oakland, California 94609 |
Greenville CCOP | Greenville, South Carolina 29615 |
Upstate Carolina CCOP | Spartanburg, South Carolina 29303 |
Danville Hematology Oncology | Danville, Virginia 24541 |
Carolina Health Care | Florence, South Carolina 29501 |
Bay Area Tumor Institute CCOP | Oakland, California 94609 |
Central Illinois CCOP | Decatur, Illinois 62526 |
Southeast Cancer Control Consortium Inc CCOP | Winston Salem, North Carolina 27104 |