NCT00058396CompletedPhase 1
Phase I Study Of IDEC-152 (Anti-CD23 Monoclonal Antibody) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Locations
- 2
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •Platelet count at least 50,000/mm^3
- •Bilirubin no greater than 2.0 mg/dL
- •AST/ALT no greater than 1.5 times upper limit of normal (ULN)
- •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
- •FEV_1 at least 60% of predicted
- •DLCO at least 55% of predicted
- •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
- •More than 4 weeks since prior major surgery (except for diagnostic surgery)
- •More than 4 weeks since prior anticancer investigational therapy
- +1 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (2)
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