Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114257
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2005-06-13
Brief Title:
Decitabine and FR901228 in Treating Patients With Relapsed or Refractory Leukemia Myelodysplastic Syndromes or Myeloproliferative Disorders
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of 5-AZA-2-Deoxycytidine and Depsipeptide in Patients With RelapsedRefractory Leukemia Myelodysplastic Syndromes or Myeloproliferative Disease
Status:
COMPLETED
Status Verified Date:
2006-09
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 I trial is studying the side effects and best dose of decitabine and FR901228 in treating patients with relapsed or refractory leukemia myelodysplastic syndromes or myeloproliferative disorders Drugs used in chemotherapy such as decitabine and FR901228 work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing FR901228 may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer Giving decitabine together with FR901228 may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose and recommended phase II dose of decitabine and FR901228 depsipeptide in patients with relapsed or refractory leukemia myelodysplastic syndromes or myeloproliferative disease
II Determine the safety and tolerability of this regimen in these patients
SECONDARY OBJECTIVES
I Determine the clinical activity of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive decitabine IV over 1 hour on days 1-5 and 8-12 and FR901228 depsipeptide IV over 4 hours on days 5 and 12 OR days 5 12 and 19 Treatment repeats every 4-6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients experiencing complete remission for 1 year are removed from the study
Cohorts of 6 patients receive escalating doses of decitabine and FR901228 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
I Determine the maximum tolerated dose and recommended phase II dose of decitabine and FR901228 depsipeptide in patients with relapsed or refractory leukemia myelodysplastic syndromes or myeloproliferative disease
II Determine the safety and tolerability of this regimen in these patients
SECONDARY OBJECTIVES
I Determine the clinical activity of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive decitabine IV over 1 hour on days 1-5 and 8-12 and FR901228 depsipeptide IV over 4 hours on days 5 and 12 OR days 5 12 and 19 Treatment repeats every 4-6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients experiencing complete remission for 1 year are removed from the study
Cohorts of 6 patients receive escalating doses of decitabine and FR901228 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting 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 |
|---|---|---|---|
| CDR0000433040 | REGISTRY | PDQ Physician Data Query | None |
| MDA-2004-0674 | None | None | None |
| NCI-5563 | None | None | None |