Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089115
Status:
TERMINATED
Last Update Posted:
2013-08-02
First Post:
2004-08-04
Brief Title:
Vaccine Therapy and Sargramostim Compared With Placebo and Sargramostim Following Rituximab in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
Favrille
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Double Blind Placebo-Controlled Trial of Favldand GM-CSF Versus Placebo and GM-CSF Following Rituximab in Subjects With Follicular B-Cell Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn as company has shut down and filed for bankruptcy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Vaccines made from a persons cancer cells may make the body build an immune response to kill cancer cells Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow and peripheral blood It is not yet known whether combining rituximab and GM-CSF with vaccine therapy may cause a stronger immune response and kill more cancer cells
PURPOSE This randomized phase III trial is studying giving rituximab and GM-CSF together with vaccine therapy and comparing it to giving rituximab and GM-CSF alone in treating patients with newly diagnosed relapsed or refractory B-cell non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying giving rituximab and GM-CSF together with vaccine therapy and comparing it to giving rituximab and GM-CSF alone in treating patients with newly diagnosed relapsed or refractory B-cell non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Compare time to disease progression in patients with grade 1 2 or 3 follicular B-cell non-Hodgkins lymphoma who respond ie complete or partial response or stable disease to treatment with rituximab and are then treated with sargramostim GM-CSF with vs without autologous immunoglobulin idiotype-KLH conjugate vaccine
Secondary
Compare response rate improvement in patients treated with these regimens
Compare overall complete response rate in patients treated with these regimens
Compare duration of response in patients treated with these regimens
Determine the safety of these regimens in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to prior treatment yes vs no and response to rituximab during study complete response CR or partial response PR vs stable disease SD
All patients receive rituximab IV once weekly for 4 weeks Five weeks after the last dose of rituximab patients are assessed for response Patients with progressive disease are removed from the study and do not undergo randomization Patients with a CR PR or SD are randomized to 1 of 2 treatment arms
Arm I Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine subcutaneously SC on day 1 Patients also receive sargramostim GM-CSF SC on days 1-4
Arm II Patients receive placebo SC on day 1 Patients also receive GM-CSF SC on days 1-4
In both arms treatment repeats monthly for 6 months in the absence of unacceptable toxicity or clinically significant progressive disease After the first 6 months patients with a CR PR or SD may continue to receive treatment per treatment arm as above every 2 months for 1 year total of 6 doses and then every 3 months thereafter in the absence of disease progression
Patients are followed every 3 months for 2 years and then every 6 months until disease progression
PROJECTED ACCRUAL A total of 342 evaluable patients 171 per treatment arm will be accrued for this study within 18 months
Primary
Compare time to disease progression in patients with grade 1 2 or 3 follicular B-cell non-Hodgkins lymphoma who respond ie complete or partial response or stable disease to treatment with rituximab and are then treated with sargramostim GM-CSF with vs without autologous immunoglobulin idiotype-KLH conjugate vaccine
Secondary
Compare response rate improvement in patients treated with these regimens
Compare overall complete response rate in patients treated with these regimens
Compare duration of response in patients treated with these regimens
Determine the safety of these regimens in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to prior treatment yes vs no and response to rituximab during study complete response CR or partial response PR vs stable disease SD
All patients receive rituximab IV once weekly for 4 weeks Five weeks after the last dose of rituximab patients are assessed for response Patients with progressive disease are removed from the study and do not undergo randomization Patients with a CR PR or SD are randomized to 1 of 2 treatment arms
Arm I Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine subcutaneously SC on day 1 Patients also receive sargramostim GM-CSF SC on days 1-4
Arm II Patients receive placebo SC on day 1 Patients also receive GM-CSF SC on days 1-4
In both arms treatment repeats monthly for 6 months in the absence of unacceptable toxicity or clinically significant progressive disease After the first 6 months patients with a CR PR or SD may continue to receive treatment per treatment arm as above every 2 months for 1 year total of 6 doses and then every 3 months thereafter in the absence of disease progression
Patients are followed every 3 months for 2 years and then every 6 months until disease progression
PROJECTED ACCRUAL A total of 342 evaluable patients 171 per treatment arm will be accrued for this study within 18 months
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 |
|---|---|---|---|
| CWRU-FVID-1404 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000378046 | REGISTRY | None | None |
| FAV-WIRB-20040335 | None | None | None |