Phase II of Interleukin-12 for Plateau Phase Multiple Myeloma
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Martha Q. Lacy, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000065934
NCT00003149
December 1997
September 2006
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
Hunterdon Regional Cancer Center | Flemington, New Jersey 08822 |
Overlook Hospital | Summit, New Jersey 07902-0220 |