Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma

Roger Williams Medical Center25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Leukemia Lymphoma

Interventions

aldesleukinBIOLOGICAL

daclizumabBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Data from ClinicalTrials.gov

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