Status:
COMPLETED
Anti-Tac(Fv)-PE38 (LMB-2) to Treat Chronic Lymphocytic Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Leukemia
Lymphocytic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the effectiveness of an experimental drug called LMB-2 for treating chronic lymphocytic leukemia (CLL) in patients who have a protein called cluster of differentiation 25 (CD2...
Detailed Description
Background: It is estimated that 30-50% of patients with CLL have tumors that express cluster of differentiation 25 (CD25) (Tac or IL2R). Normal resting T-cells are not sensitive to LMB-2 due to insu...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients must have histopathological evidence of CD25+ CLL or prolymphocytic leukemia (PLL) confirmed by the NIH pathology department. This requires that at least 50% of the peripheral malignant lymphocytes be CD25 positive by fluorescence activated cell sorting (FACS) with anti-CD25 antibody. Positive expression in a FACS assay is defined as more than 2 times the mean fluorescence intensity (MFI) of the control antibody by FACS, or greater than 400 CD25 sites/cell by FACS or radiolabeled binding assay.
- In the three stage modified Rai system, patients must be intermediate or high risk. This means they must have circulating CLL cells and at least one of the following: lymphadenopathy, splenomegaly, hepatomegaly, anemia (Hgb less than 11g/dL), or thrombocytopenia (Plt less than 100,000/ul).
- Patients must have had progressive disease after prior standard therapy containing either a purine analog or an alkylating agent.
- Patients must not have received systemic cytotoxic chemotherapy within 4 weeks of enrollment or systemic steroids (except stable doses of Prednisone less than or equal to 20 mg/day) within 4 weeks of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
- At least 18 years old.
- Patients must be able to understand and give informed consent.
- Female patients of childbearing potential must have a negative pregnancy test and all patients must use effective contraception (a barrier form of contraception).
- The transaminases alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must each be less than or equal to 2.5-times the upper limits of normal. Albumin must be greater than or equal to 3.0 gm/dL. Total bilirubin must be less than or equal to 2.2 mg/dL except in patients with Gilbert's syndrome (as defined by greater than 80% unconjugated bilirubin) it must be less than 5 mg/dl.
- The creatinine must be less than or equal to 1.4 mg/dL or the creatinine clearance must be greater than or equal to 50 ml/min as measured from a 24-hour urine collection.
- Patients should not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- EXCLUSION CRITERIA:
- Patients whose serum neutralizes LMB-2 in tissue culture, due either to anti-toxin or anti-mouse-lgG antibodies. No patient whose serum neutralizes greater than 75% of the activity of 1 micro g/mL of LMB-2 will be treated.
- Patients who received LMB-2 on another trial.
- Monoclonal antibody therapy within 12 weeks of enrollment.
- Patients who are pregnant or breast-feeding.
- Patients who are human immunodeficiency virus (HIV) positive.
- Patients who have hepatitis C or chronic liver disease. Patients would not be excluded for hepatitis B surface antigen positivity if on Lamivudine.
- Patients receiving warfarin for anticoagulation.
- Patients with a left ventricular ejection fraction of less than the institutional lower limit of normal.
- Patients with a carbon monoxide diffusing capacity (DLCO) less than 55% of normal or an forced expiratory volume 1 (FEV1) less than 60% of normal.
- Patients who have active cancer requiring treatment.
Exclusion
Key Trial Info
Start Date :
February 29 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00077922
Start Date
February 29 2004
End Date
December 31 2011
Last Update
January 23 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892