Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042822
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2002-08-05
Brief Title:
FR901228 in Treating Patients With Myelodysplastic Syndrome Acute Myeloid Leukemia or Non-Hodgkins Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study Of FR901228 Or Depsipeptide NSC 630176 For Adult Patients With Advanced Hematologic Cancers
Status:
COMPLETED
Status Verified Date:
2009-12
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of FR901228 in treating patients who have myelodysplastic syndrome acute myeloid leukemia or non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of FR901228 in treating patients who have myelodysplastic syndrome acute myeloid leukemia or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the pattern of adverse clinical experience in patients with myelodysplastic syndrome acute myeloid leukemia or intermediate-grade or follicular non-Hodgkins lymphoma treated with FR901228 depsipeptide
Determine the disease response in patients treated with this drug
Determine the pharmacokinetic and pharmacodynamic correlates of this drug including measurement of serum plasma levels H3 and H4 acetylation apoptosis induction differentiation and multidrug-resistant MDR phenotype expression in these patients
OUTLINE Patients receive FR901228 depsipeptide IV over 4 hours on days 1 and 5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed monthly
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study within 1 year
Determine the pattern of adverse clinical experience in patients with myelodysplastic syndrome acute myeloid leukemia or intermediate-grade or follicular non-Hodgkins lymphoma treated with FR901228 depsipeptide
Determine the disease response in patients treated with this drug
Determine the pharmacokinetic and pharmacodynamic correlates of this drug including measurement of serum plasma levels H3 and H4 acetylation apoptosis induction differentiation and multidrug-resistant MDR phenotype expression in these patients
OUTLINE Patients receive FR901228 depsipeptide IV over 4 hours on days 1 and 5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed monthly
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-1715 | None | None | None |
| MSKCC-00116 | None | None | None |