Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258336
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2005-11-22
Brief Title:
Rituximab Vaccine Therapy and GM-CSF in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
Favrille
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Maintenance Rituximab Plus FavId and GM-CSF Immunotherapy in Patients With Treatment-Naive Indolent B-Cell Lymphoma
Status:
UNKNOWN
Status Verified Date:
2008-08
Last Known Status:
RECRUITING
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 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 Vaccines made from a persons cancer cells may help the body build an effective immune response to kill cancer cells Colony-stimulating factors such as GM-CSF may increase the number of immune cells found in bone marrow or peripheral blood Giving rituximab together with vaccine therapy and GM-CSF may kill more cancer cells
PURPOSE This phase II trial is studying how well giving rituximab together with vaccine therapy and GM-CSF works in treating patients with indolent B-cell non-Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving rituximab together with vaccine therapy and GM-CSF works in treating patients with indolent B-cell non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the efficacy of immunotherapy comprising rituximab autologous immunoglobulin idiotype-KLH conjugate vaccine FavId and sargramostim GM-CSF in terms of response rate partial and complete and event-free survival in patients with indolent B-cell non-Hodgkins lymphoma
Determine the safety of this regimen in these patients
Evaluate development of an immune response in patients treated with this regimen
OUTLINE This is an open-label multicenter study
Induction therapy Patients receive rituximab IV over 2-4 hours once weekly for 4 weeks Patients are evaluated for response at month 3 Patients with responding or stable disease proceed to maintenance therapy Patients with progressive disease are removed from study
Maintenance therapy Patients receive rituximab as in induction therapy in months 7 13 and 19 Patients also receive autologous immunoglobulin idiotype-KLH conjugate vaccine FavId subcutaneously SC once on day 1 and sargramostim GM-CSF SC once daily on days 1-4 in months 4-6 8-11 14 16 18 20 22 and 24 Patients with continued response after completing 2 years of therapy may continue to receive FavId and GM-CSF once every 3 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 56 patients will be accrued for this study
Determine the efficacy of immunotherapy comprising rituximab autologous immunoglobulin idiotype-KLH conjugate vaccine FavId and sargramostim GM-CSF in terms of response rate partial and complete and event-free survival in patients with indolent B-cell non-Hodgkins lymphoma
Determine the safety of this regimen in these patients
Evaluate development of an immune response in patients treated with this regimen
OUTLINE This is an open-label multicenter study
Induction therapy Patients receive rituximab IV over 2-4 hours once weekly for 4 weeks Patients are evaluated for response at month 3 Patients with responding or stable disease proceed to maintenance therapy Patients with progressive disease are removed from study
Maintenance therapy Patients receive rituximab as in induction therapy in months 7 13 and 19 Patients also receive autologous immunoglobulin idiotype-KLH conjugate vaccine FavId subcutaneously SC once on day 1 and sargramostim GM-CSF SC once daily on days 1-4 in months 4-6 8-11 14 16 18 20 22 and 24 Patients with continued response after completing 2 years of therapy may continue to receive FavId and GM-CSF once every 3 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 56 patients 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 |
|---|---|---|---|
| FAV-ID-LYM-31 | None | None | None |
| FAV-ID-70 | None | None | None |