Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104884
Status:
TERMINATED
Last Update Posted:
2023-06-28
First Post:
2005-03-03
Brief Title:
FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Trial of Depsipeptide NSC 630176 in Advanced Malignant Melanoma
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated on May 17 2006 due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 unresectable stage III or stage IV malignant melanoma
PURPOSE This phase II trial is studying how well FR901228 works in treating patients with unresectable stage III or stage IV malignant melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with unresectable stage III or stage IV malignant melanoma treated with FR901228 depsipeptide
Secondary
Determine the progression-free and overall survival of patients treated with this drug
Determine the toxicity profile of this drug in these patients
OUTLINE This is a multicenter study
Patients receive FR901228 depsipeptide 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
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 22-40 patients will be accrued for this study within 18 months
Primary
Determine the response rate in patients with unresectable stage III or stage IV malignant melanoma treated with FR901228 depsipeptide
Secondary
Determine the progression-free and overall survival of patients treated with this drug
Determine the toxicity profile of this drug in these patients
OUTLINE This is a multicenter study
Patients receive FR901228 depsipeptide 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
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 22-40 patients will be accrued for this study within 18 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 |
|---|---|---|---|
| E1603 | OTHER | ECOG-ACRIN Cancer Research Group | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |