Clinical Trial: Depsipeptide (Romidepsin) in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of Single Agent Depsipeptide (FK228) in Metastatic or Unresectable Soft Tissue Sarcomas

Brief Summary: This phase II trial studies how well depsipeptide (romidepsin) works in treating patients with metastatic or unresectable soft tissue sarcoma. Drugs used in chemotherapy, such as depsipeptide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Objective Tumor Response (Complete and Partial) [ Time Frame: While on treatment - max of 16 months ]
    Estimated as the proportion of participants with partial and complete responders.
  • Time to Progression [ Time Frame: Until disease progression - max of 48 months ]
    Months from first treatment until the date of progression
  • Toxicity as Assessed Using the Expanded Common Toxicity Criteria Version 3 [ Time Frame: During treatment (max of 16 months) and for 1 month following treatment ]

    The outcome reported here is the number (%) of participants who experienced grade 3 or greater toxicity while on study.

    A summary of the individual toxicities can be found in the AE/SAE results.



Original Primary Outcome:

Current Secondary Outcome: Survival [ Time Frame: Max of 98 months ]

Months from first treatment until death or the last date of contact


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: June 2, 2005
Date Started: January 7, 2005
Date Completion:
Last Updated: April 4, 2017
Last Verified: April 2017