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Home > "L" Clinical Trials Conditions > LMB-2 Immunotoxin in Treating Patients With Chronic Lymphocytic Leukemia  LMB-2 Immunotoxin in Treating Patients With Chronic Lymphocytic Leukemia
LMB-2 Immunotoxin in Treating Patients With Chronic Lymphocytic Leukemia
For Condition: stage 1 chronic lymphocytic leukemia,stage 2 chronic lymphocytic leukemia,refractory chronic lymphocytic leukemia,stage 4 chronic lymphocytic leukemia,stage 3 chronic lymphocytic leukemia
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: LMB-2 immunotoxin can locate cancer cells and kill them without harming normal cells. This may be effective treatment for chronic lymphocytic leukemia. PURPOSE: Phase II trial to study the effectiveness of LMB-2 immunotoxin in treating patients who have chronic lymphocytic leukemia.
Details: OBJECTIVES: Primary - Determine the response rate in patients with CD25-positive chronic lymphocytic leukemia treated with LMB-2 immunotoxin. Secondary - Determine the response duration in patients treated with this drug. - Correlate blood levels of this drug with toxicity in these patients. - Determine how the development of neutralizing antibodies affects blood levels of this drug and toxicity in these patients. - Correlate soluble Tac-peptide (slL2Rα) levels with response in patients treated with this drug. 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 no more than 2 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 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 16-27 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed chronic lymphocytic leukemia - CD25-positive disease - At least 50% of peripheral malignant lymphocytes are CD25+ by fluorescence-activated cell sorting (FACS) with anti-CD25 antibody* NOTE: *Positive expression in FACS assay is defined as > 2 times the mean fluorescence intensity of the control antibody by FACS - Intermediate- or high-risk disease, meeting the following criteria: - Lymphocytosis (leukemic cells > 5,000/mm - ) AND has at least one of the following: - Lymphadenopathy - Splenomegaly - Hepatomegaly - Anemia (hemoglobin < 11g/dL) - Thrombocytopenia (platelet count < 100,000/mm^3) - Progressive disease within 2 years of prior fludarabine treatment - No serum neutralizing LMB-2 immunotoxin in tissue culture (due to either anti-toxin or anti-mouse-immunoglobulin G antibodies) - No serum neutralizing > 75% of the activity of 1μg/mL of LMB-2 immunotoxin PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - See Disease Characteristics - ALT and AST 2.5 times upper limit of normal (ULN) - Albumin 3.0 g/dL - Bilirubin 2.2 mg/dL (< 5 mg/dL in patients with Gilbert's syndrome) - Hepatitis B surface antigen negative - No hepatitis C - No chronic liver disease Renal - Creatinine 1.4 mg/dL OR - Creatinine clearance 50 mL/min Cardiovascular - LVEF lower limit of normal - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Pulmonary - DLCO 55% of normal - FEV_1 60% of normal Other - No ongoing or active infection - No other active cancer requiring treatment - No other concurrent uncontrolled illness - No psychiatric illness or social situation that would preclude study compliance - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy - More than 12 weeks since prior monoclonal antibody therapy - No prior LMB-2 immunotoxin Chemotherapy - See Disease Characteristics - More than 4 weeks since prior systemic cytotoxic chemotherapy Endocrine therapy - More than 4 weeks since prior systemic steroids except stable doses of prednisone of 20 mg/day Radiotherapy - Not specified Surgery - Not specified Other - No concurrent chronic anticoagulation
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertKreitman, Study Chair, National Cancer Institute (NCI)
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000355837; NCI-04-C-0121,NCI-6074
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080821
Other Stage 4 Chronic Lymphocytic Leukemia Studies:
1. Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia
2. LMB-2 Immunotoxin in Treating Patients With Chronic Lymphocytic Leukemia
3. Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia
4. Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
5. Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
Related Studies:
Other stage 4 chronic lymphocytic leukemia Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
LMB-2 Immunotoxin in Treating Patients With Chronic Lymphocytic Leukemia
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