Monoclonal Antibody in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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.
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.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed chronic lymphocytic leukemia OR small lymphocytic lymphoma
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Stage III-IV OR
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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
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CD23+ disease
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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
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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