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

Roger Williams Medical Center

Status and phase: Completed; Phase 2; Phase 1

Conditions: Lymphoma; Leukemia

Treatments: Biological: aldesleukin; Biological: daclizumab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00002681

NCI-H95-0732

BIDMC-FDR001054

NEDH-92020534

BIDMC-92020534

CDR0000064351

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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