Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077194
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2004-02-10
Brief Title:
FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of Depsipeptide A Histone Deacetylase Inhibitor In Relapsed Or Refractory Mantle Cell Or Diffuse Large Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2005-02
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 FR901228 works in treating patients with relapsed or refractory non-Hodgkins lymphoma Drugs used in chemotherapy such as FR901228 work in different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the response rate complete and partial in patients with relapsed or refractory Burkitts mantle cell or diffuse large cell non-Hodgkins lymphoma treated with FR901228 depsipeptide
II Determine the safety and feasibility of this drug in terms of incidence and maximum grade of toxicity and courses delayed or doses reduced in these patients
III Determine the 2-year progression-free survival and overall survival of patients treated with this drug
IV Correlate tumor expression of BCL-2 BCL-6 BAX and RAS with response in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive FR901228 depsipeptide IV over 4 hours on days 1 8 and 15 Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months until 5 years from study registration
I Determine the response rate complete and partial in patients with relapsed or refractory Burkitts mantle cell or diffuse large cell non-Hodgkins lymphoma treated with FR901228 depsipeptide
II Determine the safety and feasibility of this drug in terms of incidence and maximum grade of toxicity and courses delayed or doses reduced in these patients
III Determine the 2-year progression-free survival and overall survival of patients treated with this drug
IV Correlate tumor expression of BCL-2 BCL-6 BAX and RAS with response in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive FR901228 depsipeptide IV over 4 hours on days 1 8 and 15 Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months until 5 years from study registration
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 |
|---|---|---|---|
| CDR0000349660 | REGISTRY | PDQ Physician Data Query | None |
| MAYO-MC0287 | None | None | None |
| NCI-5961 | None | None | None |