Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112463
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2005-06-02
Brief Title:
Depsipeptide Romidepsin in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Single Agent Depsipeptide FK228 in Metastatic or Unresectable Soft Tissue Sarcomas
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA012197 | NIH | CTEP | httpsreporternihgovquickSearchP30CA012197 |
| NCI-2012-01037 | REGISTRY | None | None |
| CCCWFU 71103 | OTHER | None | None |
| 6319 | REGISTRY | None | None |
| U10CA081851 | NIH | None | None |