Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial
- 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
- 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
- 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
Richard P. Junghans, MD, PhD
Beth Israel Deaconess Medical Center
United States: Federal Government
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|