Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017290
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
2001-06-06
Brief Title:
Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkins Lymphoma
Sponsor:
Genitope Corporation
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial To Evaluate The Safety And Efficacy Of Specific Immunotherapy Recombinant Idiotype Conjugated To KLH With GM-CSF Compared To Non-Specific Immunotherapy KLH With GM-CSF In Patients With Follicular Non-Hodgkins Lymphoma
Status:
UNKNOWN
Status Verified Date:
2002-08
Last Known Status:
ACTIVE_NOT_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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Vaccines may make the body build an immune response to kill cancer cells It is not yet known which regimen of chemotherapy combined with vaccine therapy is more effective for non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to determine the effectiveness of combination chemotherapy followed by vaccine therapy plus sargramostim in treating patients who have stage III or stage IV non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to determine the effectiveness of combination chemotherapy followed by vaccine therapy plus sargramostim in treating patients who have stage III or stage IV non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare the time to tumor progression in patients with stage III or IV follicular B-cell non-Hodgkins lymphoma treated with cyclophosphamide prednisone and vincristine followed by immunotherapy with keyhole limpet hemocyanin with or without autologous tumor-derived immunoglobulin idiotype and adjuvant sargramostim GM-CSF
Compare the efficacy of these immunotherapy regimens in terms of converting patients with partial response or unconfirmed complete response to clinical complete response
Compare the safety and toxic effects of these immunotherapy regimens in this patient population
Compare the time to treatment failure and survival of patients treated with these regimens
Correlate the induction of idiotype-specific immune response with clinical benefits of achieving molecular remission in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study
Patients receive cyclophosphamide IV over 30-40 minutes and vincristine IV on day 1 Patients also receive oral prednisone on days 1-5 Treatment repeats every 21 days for 8 courses
At 6 months after completion of chemotherapy patients maintaining partial response PR complete response CR or unconfirmed complete response CRU receive immunotherapy Patients are stratified according to participating center and baseline disease status PR vs CRCRU Patients are randomized to one of two treatment arms
Arm I Patients receive autologous tumor-derived immunoglobulin idiotype conjugated to keyhole limpet hemocyanin KLH subcutaneously SC on day 1 and adjuvant sargramostim GM-CSF SC on days 1-4 of weeks 0 4 8 12 16 20 and 24
Arm II Patients receive KLH alone SC on day 1 and GM-CSF SC on days 1-4 of weeks 0 4 8 12 16 20 and 24
Quality of life is assessed prior to first immunization at 2-8 weeks after completion of immunizations and then every 6 months for 30 months
Patients are followed every 3 months for 1 year and then every 6 months thereafter Patients also enroll in a long-term follow-up study for an additional 5 years
PROJECTED ACCRUAL A total of 360 patients 240 in arm I and 120 in arm II will be accrued from the 480 patients biopsied for this study within 15-18 months
Compare the time to tumor progression in patients with stage III or IV follicular B-cell non-Hodgkins lymphoma treated with cyclophosphamide prednisone and vincristine followed by immunotherapy with keyhole limpet hemocyanin with or without autologous tumor-derived immunoglobulin idiotype and adjuvant sargramostim GM-CSF
Compare the efficacy of these immunotherapy regimens in terms of converting patients with partial response or unconfirmed complete response to clinical complete response
Compare the safety and toxic effects of these immunotherapy regimens in this patient population
Compare the time to treatment failure and survival of patients treated with these regimens
Correlate the induction of idiotype-specific immune response with clinical benefits of achieving molecular remission in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study
Patients receive cyclophosphamide IV over 30-40 minutes and vincristine IV on day 1 Patients also receive oral prednisone on days 1-5 Treatment repeats every 21 days for 8 courses
At 6 months after completion of chemotherapy patients maintaining partial response PR complete response CR or unconfirmed complete response CRU receive immunotherapy Patients are stratified according to participating center and baseline disease status PR vs CRCRU Patients are randomized to one of two treatment arms
Arm I Patients receive autologous tumor-derived immunoglobulin idiotype conjugated to keyhole limpet hemocyanin KLH subcutaneously SC on day 1 and adjuvant sargramostim GM-CSF SC on days 1-4 of weeks 0 4 8 12 16 20 and 24
Arm II Patients receive KLH alone SC on day 1 and GM-CSF SC on days 1-4 of weeks 0 4 8 12 16 20 and 24
Quality of life is assessed prior to first immunization at 2-8 weeks after completion of immunizations and then every 6 months for 30 months
Patients are followed every 3 months for 1 year and then every 6 months thereafter Patients also enroll in a long-term follow-up study for an additional 5 years
PROJECTED ACCRUAL A total of 360 patients 240 in arm I and 120 in arm II will be accrued from the 480 patients biopsied for this study within 15-18 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 |
|---|---|---|---|
| UCLA-0010061 | None | None | None |
| GENITOPE-G2000-03 | None | None | None |
| CUMC-0101-142 | None | None | None |