Status:
COMPLETED
Anti-Tac(Fv)-PE38 (LMB-2) to Treat Cutaneous T-Cell Lymphomas
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Lymphoma
T-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the effectiveness of an experimental drug called LMB-2 for treating cutaneous T-cell lymphoma in patients who have a protein called cluster of differentiation 25 (CD25) on the...
Detailed Description
Background: It is estimated that 40-50% of patients with cutaneous T-cell lymphoma (CTCL) have tumors that express cluster of differentiation 25 (CD25) (Tac or IL2Ra). Normal resting T-cells do not e...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients must have histopathological evidence of cluster of differentiation 25 (CD25) + cutaneous T-cell lymphoma (CTCL) confirmed by the National Institutes of Health (NIH) pathology department.
- One of the following must be present:
- Greater than or equal to 20 percent expression of CD25 on the lymphocytes in the skin at a site of a patch, plaque, or tumor.
- Greater than or equal to 20 percent of the peripheral blood Sezary cells must be CD25+.
- Measurable stage Ib-IV disease that has progressed after at least 2 prior systemic or topical therapies.
- Patients must have a Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 and be at least 18 years old.
- Patients must be able to understand and give informed consent.
- Patients must be 4 weeks from any monoclonal antibodies.
- Patients must be greater than or equal to 3 weeks from any CTCL-specific therapy and have evidence of progressive disease.
- Patients who are on chronic steroids must be on a stable dose of Prednisone less than or equal to 20 mg/day (or equivalent dose of another steroid) for at least 3 weeks and have evidence of progressive disease.
- Female patients of childbearing potential must have a negative pregnancy test and 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.
- The creatinine must be less than or equal to 2.0 mg/dL or the creatinine clearance must be greater than or equal to 50 ml/min.
- The absolute neutrophil count (ANC) must be greater than or equal to 1000/mm\^3 and the unsupported platelet count must be greater than or equal to 50,000/mm\^3 in patients without blood or bone marrow involvement.
- If there is blood or bone marrow involvement, the ANC must be greater than or equal to 500 mm\^3 and the platelets must be greater than or equal to 10,000/mm\^3.
- The cardiac ejection fraction as assessed by echocardiogram or nuclear medicine study must not be less than the institutional limit of normal.
- Pulmonary function studies must demonstrate a carbon monoxide diffusing capacity (DLCO) greater than or equal to 55 percent and a forced expiratory volume 1 (FEV1) greater than or equal to 60 percent of normal for inclusion.
- EXCLUSION CRITERIA:
- Patients whose serum neutralizes LMB-2 in tissue culture, due either to anti-toxin or anti-mouse-IgG antibodies.
- No patient whose serum neutralizes greater than 75 percent of the activity of 1 microg/mL of LMB-2 will be treated.
- Patients who are pregnant or breast-feeding.
- 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.
- Patients who are human immunodeficiency virus (HIV) positive,
- hepatitis B antigen positive,
- hepatitis C polymerase chain reaction (PCR) positive,
- or who have other chronic liver disease.
- Patients with symptomatic cardiac or pulmonary disease.
- Patients on warfarin therapy.
- Such patients may be eligible if they can be switched to heparin or low-molecular weight heparin therapy and are off warfarin at least 4 days prior to study enrollment.
- Active cancer requiring treatment.
Exclusion
Key Trial Info
Start Date :
April 30 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00080535
Start Date
April 30 2004
End Date
December 31 2011
Last Update
January 29 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892