Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104819
Status:
TERMINATED
Last Update Posted:
2013-08-02
First Post:
2005-03-03
Brief Title:
Vaccine Therapy and GM-CSF in Treating Patients With Progressive Non-Hodgkins Lymphoma
Sponsor:
Favrille
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of FavId Patient-Specific IdiotypeKLH and GM-CSF in Subjects Who Demonstrated Progressive Disease and Did Not Receive FavId on Study FavId-06
Status:
TERMINATED
Status Verified Date:
2008-08
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Withdrawn as company has shut down and filed for bankruptcy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 Vaccines made from a persons cancer cells may make 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 and may stimulate the immune system in different ways and stop cancer cells from growing
PURPOSE This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with progressive B-cell non-Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with progressive B-cell non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Provide treatment with autologous immunoglobulin idiotype-KLH conjugate vaccine FavId and sargramostim GM-CSF to patients with progressive grade 1 2 or 3 follicular B-cell non-Hodgkins lymphoma who did not receive FavId while enrolled on protocol FAV-ID-06
Secondary
Determine the response rate and duration of response in patients treated with this regimen
Determine the response rate and response rate improvement after best response to prior salvage therapy in patients treated with this regimen
Determine the time to progression in patients treated with this regimen
Determine the safety of this regimen in these patients
OUTLINE This is a multicenter study Patients are assigned to 1 of 2 groups according to timing of disease progression while enrolled on protocol FAV-ID-06 disease progression after prior rituximab AND never randomized vs disease progression after randomization to placebo arm
Patients receive autologous immunoglobulin idiotype-KLH vaccine subcutaneously SC on day 1 Patients also receive sargramostim GM-CSF SC on days 1-4 Treatment repeats monthly for 6 months in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease may receive additional treatment as above every 2 months for 1 year 6 treatments and every 3 months until disease progression
After completion of study treatment patients are followed for 30 days or until the start of subsequent treatment
PROJECTED ACCRUAL Approximately 238 patients 67 in group I and 171 in group II will be accrued for this study
Primary
Provide treatment with autologous immunoglobulin idiotype-KLH conjugate vaccine FavId and sargramostim GM-CSF to patients with progressive grade 1 2 or 3 follicular B-cell non-Hodgkins lymphoma who did not receive FavId while enrolled on protocol FAV-ID-06
Secondary
Determine the response rate and duration of response in patients treated with this regimen
Determine the response rate and response rate improvement after best response to prior salvage therapy in patients treated with this regimen
Determine the time to progression in patients treated with this regimen
Determine the safety of this regimen in these patients
OUTLINE This is a multicenter study Patients are assigned to 1 of 2 groups according to timing of disease progression while enrolled on protocol FAV-ID-06 disease progression after prior rituximab AND never randomized vs disease progression after randomization to placebo arm
Patients receive autologous immunoglobulin idiotype-KLH vaccine subcutaneously SC on day 1 Patients also receive sargramostim GM-CSF SC on days 1-4 Treatment repeats monthly for 6 months in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease may receive additional treatment as above every 2 months for 1 year 6 treatments and every 3 months until disease progression
After completion of study treatment patients are followed for 30 days or until the start of subsequent treatment
PROJECTED ACCRUAL Approximately 238 patients 67 in group I and 171 in group II 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 |
|---|---|---|---|
| CDR0000415573 | REGISTRY | None | None |
| CWRU-FVID-2404 | None | None | None |
| CWRU-100415 | None | None | None |
| CASE-2404 | None | None | None |
| FAV-WIRB-20041124 | Registry Identifier | PDQ Physician Data Query | None |