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| Sponsor: | Roger Williams Medical Center |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Beth Israel Deaconess Medical Center |
| Information provided by: | Roger Williams Medical Center |
| ClinicalTrials.gov Identifier: | NCT00002681 |
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 I Phase II |
| 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:
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:
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:
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
| 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 |
|
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 |
|
Leukemia Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Antibodies Daclizumab Aldesleukin |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Immunosuppressive Agents |