Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003149
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Interleukin-12 in Treating Patients With Multiple Myeloma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II of Interleukin-12 for Plateau Phase Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2009-03
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 Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a persons blood cells to kill multiple myeloma cells
PURPOSE Randomized phase II trial to compare the effectiveness of interleukin-12 given at different times in treating patients with multiple myeloma
PURPOSE Randomized phase II trial to compare the effectiveness of interleukin-12 given at different times in treating patients with multiple myeloma
Detailed Description:
OBJECTIVES I Evaluate the antitumor activity of interleukin-12 IL-12 in patients with plateau phase multiple myeloma II Evaluate the toxic effects of IL-12 in these patients III Evaluate the effectiveness of IL-12 in augmenting T helper subsets in these patients
OUTLINE This is a randomized study Patients are stratified by prior bone marrow transplantation yes vs no and by prior pneumococcal vaccine Pnu-Immune-23 yes vs no or unknown Patients are randomized to one of two treatment arms Arm I Patients receive Haemophilus influenzae b vaccine Hib TITER and Pnu-Immune-23 on day 1 during week 1 Patients who have received Pnu-Immune-23 within the past 3 years receive Hib TITER but no Pnu-Immune-23 Patients receive low dose interleukin-12 IL-12 subcutaneously SQ twice a week during weeks 1 and 2 Beginning on day 1 of week 3 patients receive high dose IL-12 SQ twice a week for an additional 12 weeks Arm II Patients receive Hib TITER and Pnu-Immune-23 as in arm I Patients undergo observation during weeks 1-4 then receive low dose IL-12 SQ twice a week during weeks 5 and 6 Beginning on day 1 of week 7 patients receive high dose IL-12 SQ twice a week for an additional 12 weeks Both arms Patients without disease progression may continue to receive high dose IL-12 for an additional 14 weeks Patients are followed every 3 months for the first 2 years every 6 months for the next 3 years and then annually thereafter until death
PROJECTED ACCRUAL A total of 40 patients 20 per arm will be accrued for this study
OUTLINE This is a randomized study Patients are stratified by prior bone marrow transplantation yes vs no and by prior pneumococcal vaccine Pnu-Immune-23 yes vs no or unknown Patients are randomized to one of two treatment arms Arm I Patients receive Haemophilus influenzae b vaccine Hib TITER and Pnu-Immune-23 on day 1 during week 1 Patients who have received Pnu-Immune-23 within the past 3 years receive Hib TITER but no Pnu-Immune-23 Patients receive low dose interleukin-12 IL-12 subcutaneously SQ twice a week during weeks 1 and 2 Beginning on day 1 of week 3 patients receive high dose IL-12 SQ twice a week for an additional 12 weeks Arm II Patients receive Hib TITER and Pnu-Immune-23 as in arm I Patients undergo observation during weeks 1-4 then receive low dose IL-12 SQ twice a week during weeks 5 and 6 Beginning on day 1 of week 7 patients receive high dose IL-12 SQ twice a week for an additional 12 weeks Both arms Patients without disease progression may continue to receive high dose IL-12 for an additional 14 weeks Patients are followed every 3 months for the first 2 years every 6 months for the next 3 years and then annually thereafter until death
PROJECTED ACCRUAL A total of 40 patients 20 per arm will be accrued for this study
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 |
|---|---|---|---|
| E-1A96 | None | None | None |