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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00080821 |
RATIONALE: LMB-2 immunotoxin can locate cancer cells and kill them without harming normal cells. This may be effective treatment for chronic lymphocytic leukemia or prolymphocytic leukemia.
PURPOSE: This phase II trial is studying how well LMB-2 immunotoxin works in treating patients with chronic lymphocytic leukemia or prolymphocytic leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: LMB-2 immunotoxin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Clinical Trial of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for Treatment of CD25 Positive Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 27 |
Study Start Date: | February 2004 |
Estimated Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive LMB-2 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression, neutralizing antibodies (i.e., > 75% of the activity of 1µg/mL of LMB-2 immunotoxin), or unacceptable toxicity.
Patients who achieve a complete response receive up to 2 additional courses of LMB-2 immunotoxin. Patients who relapse after achieving a complete or partial response for more than 2 months are eligible for retreatment as described above.
Patients are followed every 3-12 months until disease progression.
PROJECTED ACCRUAL: A total of 16-27 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
CD25-positive disease
Intermediate- or high-risk disease, meeting the following criteria:
Lymphocytosis (leukemic cells > 5,000/mm^3) AND has at least one 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: | Robert Kreitman, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000355837, NCI-04-C-0121, NCI-6074 |
Study First Received: | April 7, 2004 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00080821 |
Health Authority: | Unspecified |
refractory chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia |
stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia prolymphocytic leukemia |
Chronic lymphocytic leukemia Leukemia, Lymphoid Immunoproliferative Disorders Leukemia, B-cell, chronic Daclizumab Immunotoxins Antibodies, Monoclonal Leukemia |
Lymphatic Diseases Antibodies Leukemia, Prolymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Prolymphocytic leukemia Leukemia, B-Cell Lymphoproliferative Disorders Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |