Monoclonal Antibody in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase I Study Of IDEC-152 (Anti-CD23 Monoclonal Antibody) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia

Conditions
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Leukemia, Lymphoma

Intervention / Treatment
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* Biological: lumiliximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: lumiliximab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, noncontiguous stage II small lymphocytic lymphoma, recurrent small lymphocytic lymphoma, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, contiguous stage II small lymphocytic lymphoma