Lymphoma Clinical Trial
Official title:
Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial
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.
OBJECTIVES:
- 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.
;
Primary Purpose: Treatment
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