Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071955
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2003-11-04
Brief Title:
Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkins Lymphoma
Sponsor:
Genitope Corporation
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study to Evaluate Safety and Efficacy of Specific Immunotherapy Recombinant Idiotype Conjugated to KLH and GM-CSF Following the Anti-CD20 Antibody Rituximab in Previously Treated Patients With Follicular Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2006-01
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:
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 sargramostim may increase the number of immune cells found in bone marrow or peripheral blood
PURPOSE Phase II trial to study the effectiveness of rituximab followed by vaccine therapy and sargramostim in treating patients who have refractory or progressive non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of rituximab followed by vaccine therapy and sargramostim in treating patients who have refractory or progressive non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine progression-free survival in patients with refractory or progressive follicular non-Hodgkins lymphoma treated with immediate or delayed autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim after rituximab groups I and II
Determine the immune response rate in patients treated with these regimens groups I II and III
Determine the safety and toxicity of these regimens in these patients groups I II and III
OUTLINE This is an open-label multicenter study for patients previously registered on and confirmed ineligible for randomization in protocol Genitope-G2000-03
Patients receive rituximab IV weekly for 4 weeks
Group I The first 30 patients to achieve and maintain a partial response PR or better receive autologous immunoglobulin idiotype-KLH conjugate vaccine subcutaneously SC on day 1 and sargramostim SC on days 1-4 beginning 26 weeks after the last dose of rituximab Treatment repeats every 2 weeks for 14 weeks 8 immunizations
Group II All subsequent patients who achieve a PR or better receive autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim SC as in group I beginning 13 weeks after the last dose of rituximab
Group III Patients who are not eligible for group I or II and in the investigators opinion are suitable candidates for immunization with autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim SC receive the same treatment as groups I and II beginning no more than 1 year after the last fourth dose of rituximab
In all groups treatment continues in the absence of unacceptable toxicity or emergence of an illness that may interfere with study assessments
Patients are followed for initial response 8 weeks after completion of immunizations and then every 12 weeks for an additional year Thereafter all immunized patients will be followed every 6 months until receipt of first subsequent anti-lymphoma therapy
PROJECTED ACCRUAL Up to 120 patients will be accrued for this study
Determine progression-free survival in patients with refractory or progressive follicular non-Hodgkins lymphoma treated with immediate or delayed autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim after rituximab groups I and II
Determine the immune response rate in patients treated with these regimens groups I II and III
Determine the safety and toxicity of these regimens in these patients groups I II and III
OUTLINE This is an open-label multicenter study for patients previously registered on and confirmed ineligible for randomization in protocol Genitope-G2000-03
Patients receive rituximab IV weekly for 4 weeks
Group I The first 30 patients to achieve and maintain a partial response PR or better receive autologous immunoglobulin idiotype-KLH conjugate vaccine subcutaneously SC on day 1 and sargramostim SC on days 1-4 beginning 26 weeks after the last dose of rituximab Treatment repeats every 2 weeks for 14 weeks 8 immunizations
Group II All subsequent patients who achieve a PR or better receive autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim SC as in group I beginning 13 weeks after the last dose of rituximab
Group III Patients who are not eligible for group I or II and in the investigators opinion are suitable candidates for immunization with autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim SC receive the same treatment as groups I and II beginning no more than 1 year after the last fourth dose of rituximab
In all groups treatment continues in the absence of unacceptable toxicity or emergence of an illness that may interfere with study assessments
Patients are followed for initial response 8 weeks after completion of immunizations and then every 12 weeks for an additional year Thereafter all immunized patients will be followed every 6 months until receipt of first subsequent anti-lymphoma therapy
PROJECTED ACCRUAL Up to 120 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 |
|---|---|---|---|
| IUMC-0212-20 | None | None | None |
| GENITOPE-2002-09 | None | None | None |