Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma
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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 |
| 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) |
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 |
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| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| 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 Aldesleukin Daclizumab |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013