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Sponsors and Collaborators: |
Beth Israel Deaconess Medical Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002681 |
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 |
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Leukemia Lymphoma |
Biological: aldesleukin Biological: daclizumab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | 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 |
OBJECTIVES:
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.
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:
At least 30% of malignant cells reactive with anti-Tac as determined by immunofluorescence studies
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 |
Study ID Numbers: | CDR0000064351, BIDMC-92020534, NEDH-92020534, BIDMC-FDR001054, NCI-H95-0732 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002681 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult Hodgkin lymphoma recurrent adult acute myeloid leukemia relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia atypical chronic myeloid leukemia |
Anti-Infective Agents Immunologic Factors Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid, Acute Antibodies, Monoclonal Leukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Anti-Retroviral Agents Hodgkin Disease Lymphoma Immunoglobulins Immunoproliferative Disorders Anti-HIV Agents Hodgkin Lymphoma, Adult |
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Daclizumab Hodgkin's Disease Leukemia, Myeloid Immunosuppressive Agents Antiviral Agents Recurrence Lymphatic Diseases Antibodies Aldesleukin Interleukin-2 Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Lymphoproliferative Disorders |
Anti-Infective Agents Anti-HIV Agents Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Antineoplastic Agents Daclizumab Physiological Effects of Drugs Immunosuppressive Agents |
Antiviral Agents Pharmacologic Actions Leukemia Lymphatic Diseases Neoplasms Aldesleukin Anti-Retroviral Agents Therapeutic Uses Lymphoproliferative Disorders Lymphoma |