Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024180
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2001-09-13
Brief Title:
FR901228 in Treating Patients With Hematologic Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Depsipeptide in Selected Hematologic Malignancies NSC 630176
Status:
COMPLETED
Status Verified Date:
2002-11
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 I trial to study the effectiveness of FR901228 in treating patients who have hematologic cancer
PURPOSE Phase I trial to study the effectiveness of FR901228 in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES
Determine the in vivo biologic effect of FR901228 depsipeptide in patients with chronic lymphocytic leukemia small lymphocytic lymphoma acute myeloid leukemia or acute lymphoblastic leukemia
Determine the pharmacokinetics and cellular pharmacodynamics of this drug in these patients
Determine any preliminary anti-tumor activity of this drug in these patients
OUTLINE This is a dose-decreasing multicenter study Patients are stratified according to disease chronic lymphocytic leukemia and small lymphocytic lymphoma vs acute myeloid leukemia and acute lymphoblastic leukemia
Patients receive FR901228 depsipeptide IV over 4 hours on days 1 8 and 15 Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity
Cohorts of 10 patients per stratum receive decreasing doses of FR901228 until the minimal active dose is determined If 5 or more patients show clinical or biological response the subsequent cohort is treated at a lower dose If fewer than 5 patients respond the subsequent cohort is treated at a higher dose
PROJECTED ACCRUAL A minimum of 20 patients 10 per stratum will be accrued for this study
Determine the in vivo biologic effect of FR901228 depsipeptide in patients with chronic lymphocytic leukemia small lymphocytic lymphoma acute myeloid leukemia or acute lymphoblastic leukemia
Determine the pharmacokinetics and cellular pharmacodynamics of this drug in these patients
Determine any preliminary anti-tumor activity of this drug in these patients
OUTLINE This is a dose-decreasing multicenter study Patients are stratified according to disease chronic lymphocytic leukemia and small lymphocytic lymphoma vs acute myeloid leukemia and acute lymphoblastic leukemia
Patients receive FR901228 depsipeptide IV over 4 hours on days 1 8 and 15 Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity
Cohorts of 10 patients per stratum receive decreasing doses of FR901228 until the minimal active dose is determined If 5 or more patients show clinical or biological response the subsequent cohort is treated at a lower dose If fewer than 5 patients respond the subsequent cohort is treated at a higher dose
PROJECTED ACCRUAL A minimum of 20 patients 10 per stratum will be accrued for this study
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 |
|---|---|---|---|
| OSU-00H0350 | None | None | None |
| NCI-27 | None | None | None |