Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00288067
Status:
TERMINATED
Last Update Posted:
2014-10-06
First Post:
2006-02-06
Brief Title:
Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I-II Trial of Fenretinide 4-HPR Rituximab in Patients With B-cell Lymphoma
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
NCI stopped supplying fenretinide in November of 2012
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 side effects and best dose of fenretinide and to see how well it works when given together with rituximab in treating patients with B-cell non-Hodgkin lymphoma Drugs used in chemotherapy such as fenretinide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as rituximab can block cancer growth in different ways Some find cancer cells and kill them or carry cancer-killing substances to them Others interfere with the ability of cancer cells to grow and spread Giving fenretinide together with rituximab may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the safety of fenretinide delivered in a 5 of 7 day regimen Phase I II To estimate the efficacy response rates of fenretinide rituximab in patients with B-cell non-Hodgkin lymphoma NHL Phase II
SECONDARY OBJECTIVES
I To perform pharmacokinetic studies on patients receiving fenretinide Phase I II To determine the intratumoral concentrations of fenretinide Phase I III To evaluate the in vivo mechanism of action of fenretinide Phase I IV To identify the predictors of response to fenretinide Phase I V To estimate the response rates positron emission tomography PET response overall survival OS progression-free survival PFS time to progression TTP and disease-free survival DFS of patients treated on this study Phase I VI To estimate the overall survival OS progression-free survival PFS time to progression TTP disease-free survival DFS and PET responses of patients treated on this study Phase II VII To perform pharmacokinetic studies on patients receiving fenretinide Phase II VIII To determine the intratumoral concentration of fenretinide Phase II IX To identify the predictors of response to fenretinide and fenretinide rituximab in B-NHL Phase II X To evaluate the in vivo mechanism of action of fenretinide in B-NHL Phase II
OUTLINE This is a phase I dose-escalation study of fenretinide followed by a phase II study
PHASE I Patients receive fenretinide orally PO twice daily BID on days 1-5 Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity
PHASE II Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab intravenously IV once weekly in weeks 5-8 Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically
I To evaluate the safety of fenretinide delivered in a 5 of 7 day regimen Phase I II To estimate the efficacy response rates of fenretinide rituximab in patients with B-cell non-Hodgkin lymphoma NHL Phase II
SECONDARY OBJECTIVES
I To perform pharmacokinetic studies on patients receiving fenretinide Phase I II To determine the intratumoral concentrations of fenretinide Phase I III To evaluate the in vivo mechanism of action of fenretinide Phase I IV To identify the predictors of response to fenretinide Phase I V To estimate the response rates positron emission tomography PET response overall survival OS progression-free survival PFS time to progression TTP and disease-free survival DFS of patients treated on this study Phase I VI To estimate the overall survival OS progression-free survival PFS time to progression TTP disease-free survival DFS and PET responses of patients treated on this study Phase II VII To perform pharmacokinetic studies on patients receiving fenretinide Phase II VIII To determine the intratumoral concentration of fenretinide Phase II IX To identify the predictors of response to fenretinide and fenretinide rituximab in B-NHL Phase II X To evaluate the in vivo mechanism of action of fenretinide in B-NHL Phase II
OUTLINE This is a phase I dose-escalation study of fenretinide followed by a phase II study
PHASE I Patients receive fenretinide orally PO twice daily BID on days 1-5 Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity
PHASE II Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab intravenously IV once weekly in weeks 5-8 Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically
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 |
|---|---|---|---|
| R21CA119519 | NIH | CTEP | httpsreporternihgovquickSearchR21CA119519 |
| NCI-2009-00104 | REGISTRY | None | None |
| CDR0000456502 | OTHER | None | None |
| UWCC-UW-6071 | OTHER | None | None |
| UWCC-06-0644-HA | OTHER | None | None |
| UWCC-6071 | OTHER | None | None |
| FHCRC-6071 | OTHER | None | None |
| 6071 | OTHER | None | None |
| 6957 | OTHER | None | None |