Interleukin-12 Plus Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
RATIONALE: Interleukin-12 may stimulate a person's white blood cells to kill lymphoma cells. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of interleukin-12 plus rituximab in treating patients who have non-Hodgkin's lymphoma.
|Lymphoma||Biological: recombinant interleukin-12 Biological: rituximab||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of Interleukin-12 in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma|
|Study Start Date:||October 1999|
|Study Completion Date:||June 2003|
|Primary Completion Date:||June 2003 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the optimal immunological dose of interleukin-12 and rituximab when administered in combination in patients with non-Hodgkin's lymphoma. II. Determine the toxicities associated with this regimen in this patient population. III. Assess the pharmacodynamics of this regimen in these patients. IV. Document observed clinical response to this regimen in these patients.
OUTLINE: This is a dose escalation study of interleukin-12. Patients receive rituximab IV on days 1, 8, 15, and 22. The first cohort of patients receives interleukin-12 SC twice weekly beginning on day 29. Subsequent cohorts receive interleukin-12 SC twice weekly beginning on day 16. Patients with stable or responding disease may continue treatment with interleukin-12 twice weekly for up to 24 weeks or until disease progression. Cohorts of 6-9 patients receive escalating doses of interleukin-12 until the optimal immunological dose is determined. The optimal immunological dose is defined as the dose preceding that at which 2 of 6 or 2 of 9 patients experience dose limiting toxicities or the dose at which there is a maximal increase in gamma interferon, inducible protein-10 (IP-10) and immune cell infiltration into the lymphoma (whichever dose is lower). Following initial dose escalation, 2 additional cohorts of 6 patients receive a fixed dose of interleukin-12 SC twice weekly beginning on day 2. Patients are followed every 3 months for the first year, and then every 6 months for the next 4 years or until disease progression.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 12-13 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004260
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Stephen M. Ansell, MD, PhD||Mayo Clinic|