monoclonal antibody plus interleukin-2 in treating patients with leukemia or lymphoma

Conditions: Leukemia; Lymphoma

Summary: 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.

Eligibility criteria:
disease characteristics: * histologically confirmed diagnosis of one of the following malignancies: * hodgkin's lymphoma * acute myelogenous leukemia * chronic myelogenous leukemia * failed standard therapy or in chronic phase if on standard therapy * at least 30% of malignant cells reactive with anti-tac as determined by immunofluorescence studies * all hodgkin's lymphoma patients eligible due to 100% tac-positivity of reed-sternberg cells * measurable disease * no symptomatic cns disease patient characteristics: age: * 18 and over performance status: * 0-2 life expectancy: * greater than 2 months hematopoietic: * not specified hepatic: * bilirubin no greater than 3 times normal * no significant hepatic disease renal: * creatinine no greater than 3 times normal * no significant renal disease cardiovascular: * no significant cardiovascular disease pulmonary: * no significant pulmonary disease other: * no significant endocrine, rheumatologic, or allergic disease * no hiv-i antibody * no active disease due to any of the following: * cytomegalovirus herpes simplex virus i/ii * hepatitis b or c tuberculosis * negative pregnancy test required of fertile women prior concurrent therapy: biologic therapy: * no prior murine anti-tac monoclonal antibody chemotherapy: * at least 4 weeks since chemotherapy endocrine therapy: * not specified radiotherapy: * at least 4 weeks since radiotherapy surgery: * not specified other: * concurrent treatment allowed for complications of primary disease

Keywords: recurrent adult hodgkin lymphoma recurrent adult acute myeloid leukemia relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia atypical chronic myeloid leukemia, bcr-abl negative