Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.


Study summary:

OBJECTIVES: - Determine a recommended phase II dose of IDEC-152 monoclonal antibody in patients with relapsed or recurrent chronic lymphocytic leukemia. - Determine the safety profile of this drug in these patients. - Determine the pharmacokinetics and pharmacodynamics of this drug in these patients. - Determine the efficacy of this drug in these patients. OUTLINE: This is an open-label, multicenter, dose-escalation study. Patients receive IDEC-152 monoclonal antibody IV over at least 2 hours on days 1, 2, 8, 15, and 22. Cohorts of 3-10 patients receive escalating doses of IDEC-152 monoclonal antibody until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3, 2 of 6, or 3 of 10 patients experience dose-limiting toxicity. Patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 15-50 patients will be accrued for this study within 6 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed chronic lymphocytic leukemia OR small lymphocytic lymphoma - Stage III-IV OR - Stage I-II, if determined to have disease progression evidenced by 1 of the following characteristics: - Rapid doubling of peripheral lymphocyte count - Progressive lymphadenopathy - Progressive splenomegaly - B symptoms - Grade 2 or 3 fatigue - CD23+ disease - Progressive disease after at least 1 prior chemotherapy course PATIENT CHARACTERISTICS: Age - 18 and over Performance status - WHO 0-2 Life expectancy - At least 6 months Hematopoietic - Platelet count at least 50,000/mm^3 Hepatic - Bilirubin no greater than 2.0 mg/dL - AST/ALT no greater than 1.5 times upper limit of normal (ULN) Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No New York Heart Association class III or IV cardiac disease - No myocardial infarction within the past 6 months - No unstable arrhythmia - No evidence of ischemia on EKG within the past 14 days Pulmonary - FEV_1 at least 60% of predicted - DLCO at least 55% of predicted Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study treatment - HIV negative - No secondary malignancy requiring active treatment (except hormonal therapy) - No serious nonmalignant disease that would preclude study participation - No active uncontrolled bacterial, viral, or fungal infection - No clinically active autoimmune disease PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior anticancer biologic therapy - More than 4 weeks since prior anticancer radioimmunotherapy - No prior exposure to IDEC-152 or anti-CD23 antibodies Chemotherapy - See Disease Characteristics - More than 4 weeks since prior anticancer chemotherapy Endocrine therapy - Concurrent hormonal therapy allowed for second malignancy Radiotherapy - More than 4 weeks since prior anticancer radiotherapy Surgery - More than 4 weeks since prior major surgery (except for diagnostic surgery) Other - More than 4 weeks since prior anticancer investigational therapy - No other concurrent anticancer therapy


NCT ID:

NCT00058396


Primary Contact:

Study Chair
Mark Adam Weiss, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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