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

This study has been completed.
Beth Israel Deaconess Medical Center
Information provided by:
Roger Williams Medical Center Identifier:
First received: November 1, 1999
Last updated: June 9, 2011
Last verified: June 2011

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.

Condition Intervention Phase
Biological: aldesleukin
Biological: daclizumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial

Resource links provided by NLM:

Further study details as provided by Roger Williams Medical Center:

Estimated Enrollment: 25
Study Start Date: July 1995
Study Completion Date: December 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • 0-2

Life expectancy:

  • Greater than 2 months


  • Not specified


  • Bilirubin no greater than 3 times normal
  • No significant hepatic disease


  • Creatinine no greater than 3 times normal
  • No significant renal disease


  • No significant cardiovascular disease


  • No significant pulmonary disease


  • 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


Biologic therapy:

  • No prior murine anti-Tac monoclonal antibody


  • At least 4 weeks since chemotherapy

Endocrine therapy:

  • Not specified


  • At least 4 weeks since radiotherapy


  • Not specified


  • Concurrent treatment allowed for complications of primary disease
  Contacts and Locations
Please refer to this study by its identifier: NCT00002681

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Roger Williams Medical Center
Beth Israel Deaconess Medical Center
Study Chair: Richard P. Junghans, MD, PhD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Richard Junghans, Roger Williams Medical Center Identifier: NCT00002681     History of Changes
Other Study ID Numbers: CDR0000064351, BIDMC-92020534, NEDH-92020534, BIDMC-FDR001054, NCI-H95-0732
Study First Received: November 1, 1999
Last Updated: June 9, 2011
Health Authority: United States: Federal Government

Keywords provided by Roger Williams Medical Center:
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

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents processed this record on April 17, 2014