- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002681
Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma
Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Richard P. Junghans, MD, PhD, Beth Israel Deaconess Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Leukemia
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Aldesleukin
- Daclizumab
Other Study ID Numbers
- CDR0000064351
- BIDMC-92020534
- NEDH-92020534
- BIDMC-FDR001054
- NCI-H95-0732
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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