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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020020 |
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying how well daclizumab works in treating patients with adult T-cell leukemia/lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: daclizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of the Efficacy and Toxicity of Humanized Anti-Tac (Zenapax) in the Therapy of Tac-Expressing Adult T-Cell Leukemia |
Estimated Enrollment: | 53 |
Study Start Date: | March 2000 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE:
This is a dose-escalation study.
The first cohort of 3 patients receives daclizumab IV over 30 minutes on days 1 and 2. The subsequent 3 cohorts of 3-6 patients receive daclizumab IV over 90 minutes on day 1. In the absence of disease progression or unacceptable toxicity, patients receive up to 5 additional courses of daclizumab at the dose level of the cohort being studied at weeks 2, 5, 8, 11, and 14.
Cohorts of 3-6 patients receive escalating doses of daclizumab until the saturating dose is achieved or until the maximum tolerated dose (MTD) is determined. The saturating dose is defined as the dose at which 6 of 6 patients have adult T-cell leukemia cells saturated at 6-72 hours after initial daclizumab administration and then at 2 and 5 weeks prior to subsequent daclizumab administration. The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients receive daclizumab at the saturating dose from phase I of the study. If a saturating dose was not achieved by the fourth cohort during phase I, then the fourth cohort dose level is used for phase II of the study.
Patients who achieve and maintain a partial response to treatment after 6 courses in the absence of dose-limiting toxicity may continue to receive daclizumab for a total of 24 months.
Patients are followed every 2 months for 1 year.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
Ages Eligible for Study: | 10 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven Tac-expressing adult T-cell leukemia/lymphoma (ATL), including any of the folllowing stages:
Smoldering, meeting the following criteria:
No symptomatic CNS disease due to ATL
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Study Chair: | Thomas A. Waldmann, MD | NCI - Metabolism Branch;MET |
Study ID Numbers: | CDR0000067556, NCI-00-C-0030J |
Study First Received: | July 11, 2001 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00020020 |
Health Authority: | Unspecified |
stage I adult T-cell leukemia/lymphoma stage II adult T-cell leukemia/lymphoma stage III adult T-cell leukemia/lymphoma |
stage IV adult T-cell leukemia/lymphoma recurrent adult T-cell leukemia/lymphoma angioimmunoblastic T-cell lymphoma |
Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Daclizumab Leukemia-Lymphoma, Adult T-Cell |
Lymphoma, T-Cell Immunoblastic Lymphadenopathy Leukemia, T-Cell Lymphoproliferative Disorders Lymphoma Recurrence |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases |
Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |