Interleukin-12 in Treating Patients With Multiple Myeloma
RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's 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.
Multiple Myeloma and Plasma Cell Neoplasm
Biological: recombinant interleukin-12
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Phase II of Interleukin-12 for Plateau Phase Multiple Myeloma|
|Study Start Date:||December 1997|
|Study Completion Date:||September 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003149
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|Veterans Affairs Medical Center - Indianapolis (Roudebush)|
|Indianapolis, Indiana, United States, 46202|
|United States, Iowa|
|CCOP - Iowa Oncology Research Association|
|Des Moines, Iowa, United States, 50309-1016|
|United States, Louisiana|
|CCOP - Ochsner|
|New Orleans, Louisiana, United States, 70121|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, New Jersey|
|Hunterdon Regional Cancer Center|
|Flemington, New Jersey, United States, 08822|
|Morristown Memorial Hospital|
|Morristown, New Jersey, United States, 07962-1956|
|Summit, New Jersey, United States, 07902-0220|
|United States, New York|
|University of Rochester Cancer Center|
|Rochester, New York, United States, 14642|
|United States, Pennsylvania|
|Hahnemann University Hospital|
|Philadelphia, Pennsylvania, United States, 19102-1192|
|Study Chair:||Martha Q. Lacy, MD||Mayo Clinic|