Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill leukemia or lymphoma cells. Combining these two therapies may be an effective treatment for leukemia and lymphoma.
PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy plus interleukin-2 in treating patients who have leukemia or lymphoma.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial|
|Study Start Date:||July 1995|
|Study Completion Date:||December 2003|
|Primary Completion Date:||September 2003 (Final data collection date for primary outcome measure)|
- Assess the safety and tolerability of a multidose regimen of humanized anti-Tac monoclonal antibody (HAT) and interleukin-2 (IL-2) in patients with leukemia and lymphoma.
- Describe the pharmacokinetics/pharmacodynamics of HAT and IL-2 in a multidose schedule, including serum half-life of free HAT, area under the curve, and volume of distribution.
- Evaluate the immunogenicity of HAT.
- Identify immunologic parameters that correlate with efficacy.
- Evaluate the preliminary efficacy of HAT in these patients.
- Monitor patients receiving indium-111-labeled HAT for circulating infused antibody for pharmacokinetics, tumor imaging, and bioactivity (binding ability).
OUTLINE: Patients are stratified according to disease (Hodgkin's lymphoma vs acute myelogenous leukemia vs chronic myelogenous leukemia).
Patients receive humanized anti-TAC monoclonal antibody (HAT) IV over 30 minutes on day 1, then IV over 30 minutes every 7 days and interleukin-2 subcutaneously daily. Treatment continues for up to 1 year in the absence of disease progression, unacceptable toxicity, or development of neutralizing antibodies.
Patients are followed weekly for 2 months.
PROJECTED ACCRUAL: A total of 25 patients with Hodgkin's lymphoma and 14 each with AML and CML will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002681
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Study Chair:||Richard P. Junghans, MD, PhD||Beth Israel Deaconess Medical Center|