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Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Beth Israel Deaconess Medical Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002681
  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
Drug: aldesleukin
Drug: daclizumab
Phase I
Phase II

MedlinePlus related topics: Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma
Drug Information available for: Aldesleukin Immunoglobulins Globulin, Immune Interleukin-2 Dacliximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: HUMANIZED ANTI-TAC ANTIBODY THERAPY IN HODGKIN'S DISEASE, A PHASE IB/II TRIAL

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 25
Study Start Date: July 1995
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
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
Beth Israel Deaconess Medical Center
Investigators
Study Chair: Richard P. Junghans, MD, PhD Beth Israel Deaconess Medical Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000064351, BIDMC-92020534, NEDH-92020534, BIDMC-FDR001054, NCI-H95-0732
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00002681  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma
recurrent adult acute myeloid leukemia
relapsing chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
atypical chronic myeloid leukemia

Study placed in the following topic categories:
Hodgkin's disease
Immunoproliferative Disorders
Chronic myelogenous leukemia
Daclizumab
Hodgkin lymphoma, adult
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Acute myelogenous leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid, Acute
Recurrence
Antibodies, Monoclonal
Leukemia
Lymphatic Diseases
Antibodies
Aldesleukin
Interleukin-2
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Acute myeloid leukemia, adult
Lymphoproliferative Disorders
Acute myelocytic leukemia
Lymphoma
Hodgkin Disease
Immunoglobulins

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Anti-HIV Agents
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Anti-Retroviral Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009