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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-07-31

Study Completion Date

2003-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Rituximab and Interleukin-12 in Treating Patients With B-Cell Non-Hodgkin's Lymphoma

NCT00026182

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Recurrent Grade 1 Follicular Lymphoma +4 more

COMPLETED PHASE2

Rituximab Plus Interleukin-2 in Treating Patients With Hematologic Cancer

NCT00010192

B-cell Adult Acute Lymphoblastic Leukemia Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma +50 more

COMPLETED PHASE1

Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma

NCT00059904

Lymphoma

COMPLETED PHASE2

Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma

NCT00004858

Leukemia Lymphoma

UNKNOWN PHASE1

Rituximab Plus Interleukin-2 in Treating Patients With Lymphoma

NCT00003356

Lymphoma

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leukemia Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

aldesleukin

Intervention Type BIOLOGICAL

daclizumab

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No