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

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Information provided by:
Roger Williams Medical Center
ClinicalTrials.gov Identifier:
NCT00002681
First received: November 1, 1999
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

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
Leukemia
Lymphoma
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:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002681

Locations
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
Investigators
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
ClinicalTrials.gov 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:
Leukemia
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Daclizumab
Aldesleukin
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

ClinicalTrials.gov processed this record on August 01, 2014