Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062075
Status:
COMPLETED
Last Update Posted:
2015-12-04
First Post:
2003-06-05
Brief Title:
Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of Depsipeptide in Patients With Relapsed or Refractory AML
Status:
COMPLETED
Status Verified Date:
2013-04
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 is studying how well romidepsin works in treating patients with relapsed or refractory acute myeloid leukemia Drugs used in chemotherapy such as romidepsin work in different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I Determine the complete and partial response rate in patients with relapsed or refractory acute myeloid leukemia treated with FR901228 depsipeptide
II Determine the toxicity of this drug in these patients III Correlate clinical response with specific cytogenetic abnormalities in patients treated with this drug
OUTLINE Patients are stratified according to the presence of a specific chromosomal abnormality t821 vs inv 16 vs t1517 vs absence of these chromosomal abnormalities
Patients receive romidepsin IV over 4 hours on days 1 8 and 15
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
I Determine the complete and partial response rate in patients with relapsed or refractory acute myeloid leukemia treated with FR901228 depsipeptide
II Determine the toxicity of this drug in these patients III Correlate clinical response with specific cytogenetic abnormalities in patients treated with this drug
OUTLINE Patients are stratified according to the presence of a specific chromosomal abnormality t821 vs inv 16 vs t1517 vs absence of these chromosomal abnormalities
Patients receive romidepsin IV over 4 hours on days 1 8 and 15
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| P30CA014599 | NIH | None | httpsreporternihgovquickSearchP30CA014599 |
| 12209B | None | None | None |
| CDR0000304460 | None | None | None |
| N01CM62201 | NIH | None | None |
| N01CM17102 | NIH | None | None |
| U01CA099177 | NIH | None | None |