Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026182
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2001-11-09
Brief Title:
Rituximab and Interleukin-12 in Treating Patients With B-Cell Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase II Study Of Interleukin-12 In Combination With Rituximab In Patients With Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-08
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:
Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Interleukin-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a persons white blood cells to kill cancer cells Combining rituximab with interleukin-12 may kill more cancer cells This randomized phase II trial is comparing how well giving rituximab together with two different schedules of interleukin-12 works in treating patients with B-cell non-Hodgkin lymphoma
Detailed Description:
OBJECTIVES
I Compare the objective response in patients with B-cell non-Hodgkins lymphoma treated with rituximab and 2 different schedules of interleukin-12
II Compare the toxic effects of these regimens in these patients III Determine the objective response rate in patients with mantle cell lymphoma treated with these regimens
IV Determine the overall and progression-free survival of patients treated with these regimens
V Compare the quality of life of patients treated with these regimens NOTE Interleukin-12 will no longer be available after 63005
OUTLINE This is a randomized multicenter study Patients are stratified according to histology mantle cell lymphoma vs other closed to accrual as of 31004 and International Prognostic Factor Index low and low-intermediate risk closed to accrual as of 31004 vs high-intermediate and high risk Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive rituximab IV on days 1 8 15 and 22 Patients receive interleukin-12 subcutaneously SC twice weekly beginning on day 2 and continuing until disease progression
ARM II closed to accrual as of 111403 Patients receive rituximab as in arm I Patients are evaluated at week 12 Patients with stable or progressive disease receive interleukin-12 SC twice weekly until disease progression or for 24 weeks Patients with a complete or partial response after rituximab are monitored until disease progression and then begin interleukin-12 SC twice weekly until further disease progression
NOTE Interleukin-12 will no longer be available after 063005 Patients proceed to follow-up as outlined below
Quality of life is assessed at baseline and at 3 and 6 months
Patients are followed every 3 months for 1 year and then every 6 months for up to 4 years
PROJECTED ACCRUAL A total of 90 patients 45 per treatment arm arm II closed to accrual as of 111403 will be accrued for this study within 3 years
I Compare the objective response in patients with B-cell non-Hodgkins lymphoma treated with rituximab and 2 different schedules of interleukin-12
II Compare the toxic effects of these regimens in these patients III Determine the objective response rate in patients with mantle cell lymphoma treated with these regimens
IV Determine the overall and progression-free survival of patients treated with these regimens
V Compare the quality of life of patients treated with these regimens NOTE Interleukin-12 will no longer be available after 63005
OUTLINE This is a randomized multicenter study Patients are stratified according to histology mantle cell lymphoma vs other closed to accrual as of 31004 and International Prognostic Factor Index low and low-intermediate risk closed to accrual as of 31004 vs high-intermediate and high risk Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive rituximab IV on days 1 8 15 and 22 Patients receive interleukin-12 subcutaneously SC twice weekly beginning on day 2 and continuing until disease progression
ARM II closed to accrual as of 111403 Patients receive rituximab as in arm I Patients are evaluated at week 12 Patients with stable or progressive disease receive interleukin-12 SC twice weekly until disease progression or for 24 weeks Patients with a complete or partial response after rituximab are monitored until disease progression and then begin interleukin-12 SC twice weekly until further disease progression
NOTE Interleukin-12 will no longer be available after 063005 Patients proceed to follow-up as outlined below
Quality of life is assessed at baseline and at 3 and 6 months
Patients are followed every 3 months for 1 year and then every 6 months for up to 4 years
PROJECTED ACCRUAL A total of 90 patients 45 per treatment arm arm II closed to accrual as of 111403 will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA025224 | NIH | CTEP | httpsreporternihgovquickSearchU10CA025224 |
| NCI-2012-01865 | REGISTRY | None | None |
| NCCTG-N0087 | None | None | None |
| CDR0000068994 | None | None | None |
| N0087 | OTHER | None | None |
| N0087 | OTHER | None | None |