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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial

Conditions
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Leukemia, Lymphoma

Intervention / Treatment
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* Biological: aldesleukin
* Biological: daclizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Biological: daclizumab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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