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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002681
• Other study ID #: CDR0000064351
• Secondary ID: BIDMC-92020534NE
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 1, 1999
• Last updated: June 9, 2011
• Start date: July 1995
• Est. completion date: December 2003

Study information

• Verified date: June 2011
• Source: Roger Williams Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Lymphoma

Intervention

Biological:
• aldesleukin

• daclizumab

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Roger Williams Medical Center	Beth Israel Deaconess Medical Center, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,