Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00079196 |
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 I trial is studying the side effects and best dose of a monoclonal antibody in treating patients with T-cell large granular lymphocyte leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Biological: monoclonal antibody Mik-beta-1 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I Open-Lable Single-Dose Study of Humanized MIK-BETA-1 Monoclonal Antibody Directed Toward the IL-2R/IL-15R Beta Subunit (CD122) in T Cell Large Granular Lymphocytic Leukemia |
Estimated Enrollment: | 18 |
Study Start Date: | December 2004 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study.
Patients receive a single dose of humanized monoclonal antibody MiK-beta-1 IV over 90 minutes on day 1.
Cohorts of 3-6 patients receive escalating doses of humanized monoclonal antibody MiK-beta-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 2, 3, 4, and 6 weeks and then every 3 months for 9 months.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 2.5-3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed T-cell large granular lymphocyte leukemia (T-LGL) as defined by the following:
T-LGL-associated hemocytopenia, defined by at least 1 of the following:
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, 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 |
Principal Investigator: | John C. Morris, MD | NCI - Metabolism Branch;MET |
Study ID Numbers: | CDR0000355111, NCI-04-C-0089 |
Study First Received: | March 8, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00079196 History of Changes |
Health Authority: | Unspecified |
refractory chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia T-cell large granular lymphocyte leukemia |
Leukemia, Lymphoid Immunoproliferative Disorders Immunologic Factors Large Granular Lymphocyte Leukemia Antibodies, Monoclonal Leukemia Lymphatic Diseases Chronic Lymphocytic Leukemia |
Antibodies Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, T-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic Immunoglobulins Leukemia, Large Granular Lymphocytic |
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibodies, Monoclonal |
Leukemia Lymphatic Diseases Neoplasms Antibodies Leukemia, T-Cell Lymphoproliferative Disorders Leukemia, Large Granular Lymphocytic |