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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00080821 |
Purpose
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 |
Biological: 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.
Eligibility| 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
Contacts and Locations| 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) |
More Information
| Responsible Party: | NCI - Center for Cancer Research ( Robert Kreitman ) |
| Study ID Numbers: | CDR0000355837, NCI-04-C-0121, NCI-6074 |
| Study First Received: | April 7, 2004 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00080821 History of Changes |
| 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 |
|
Leukemia, Lymphoid Immunoproliferative Disorders Prolymphocytic Leukemia Immunologic Factors Daclizumab Immunotoxins Antibodies, Monoclonal Leukemia Lymphatic Diseases |
Antibodies Chronic Lymphocytic Leukemia Leukemia, Prolymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic Immunoglobulins |
|
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions Immunotoxins |
Antibodies, Monoclonal Leukemia Lymphatic Diseases Neoplasms Leukemia, Prolymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-Cell Lymphoproliferative Disorders |