Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079443
Status:
TERMINATED
Last Update Posted:
2013-07-01
First Post:
2004-03-08
Brief Title:
FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Single Agent Depsipeptide NSC 630176 Followed by a Phase I Study of RituximabFludarabine Combination With an Escalating Dose of Depsipeptide in Relapsed or Refractory Low Grade B Cell Lymphomas
Status:
TERMINATED
Status Verified Date:
2013-06
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 III trial is studying the best dose of FR901228 when given together with rituximab and fludarabine and to see how well FR901228 works alone in treating patients with relapsed or refractory low-grade B-cell non-Hodgkins lymphoma Drugs used in chemotherapy such as FR901228 and fludarabine work in different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Rituximab may increase the effectiveness of chemotherapy drugs by making cancer cells more sensitive to the drugs
Detailed Description:
PRIMARY OBJECTIVES
I For phase 2 is to assess the clinical efficacy complete and partial response rates of single agent depsipeptide
II For phase 1 is to assess the feasibility of adding Depsipeptide to a regimen of Rituximab and Fludarabine and to establish the MTD of Depsipeptide in this combination
SECONDARY OBJECTIVES
I To correlate disease response clinical outcome with the changes in histone acetylation assays
II Study the expression of death receptors of DR4 and DR5 after treatment with depsipeptide
III Assessment of minimal residual disease by immune histochemistry
OUTLINE This is a multicenter phase II study of single-agent FR901228 followed by a phase I dose-escalation study of FR901228
PHASE II Patients receive FR901228 IV over 4 hours on days 1 8 and 15 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients who achieve a complete or partial remission receive 2 additional courses for a total of 6 courses Patients with stable disease after 4 courses or progressive disease at any time after 2 courses proceed to the phase I portion of the study
PHASE I Patients receive rituximab IV over approximately 4-8 hours on day 1 fludarabine IV over 10-30 minutes on days 2-4 and FR901228 IV over 4 hours on days 2 9 and 16 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of 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
Patients are followed for up to 3 years from study entry
I For phase 2 is to assess the clinical efficacy complete and partial response rates of single agent depsipeptide
II For phase 1 is to assess the feasibility of adding Depsipeptide to a regimen of Rituximab and Fludarabine and to establish the MTD of Depsipeptide in this combination
SECONDARY OBJECTIVES
I To correlate disease response clinical outcome with the changes in histone acetylation assays
II Study the expression of death receptors of DR4 and DR5 after treatment with depsipeptide
III Assessment of minimal residual disease by immune histochemistry
OUTLINE This is a multicenter phase II study of single-agent FR901228 followed by a phase I dose-escalation study of FR901228
PHASE II Patients receive FR901228 IV over 4 hours on days 1 8 and 15 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients who achieve a complete or partial remission receive 2 additional courses for a total of 6 courses Patients with stable disease after 4 courses or progressive disease at any time after 2 courses proceed to the phase I portion of the study
PHASE I Patients receive rituximab IV over approximately 4-8 hours on day 1 fludarabine IV over 10-30 minutes on days 2-4 and FR901228 IV over 4 hours on days 2 9 and 16 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of 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
Patients are followed for up to 3 years from study entry
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 |
|---|---|---|---|
| U01CA069854 | NIH | None | httpsreporternihgovquickSearchU01CA069854 |
| UMGCC 0307 | None | None | None |
| MSGCC-0307 | None | None | None |
| CDR0000355763 | None | None | None |
| NCI-6015 | None | None | None |