Leukemia, Lymphoma
Conditions
Keywords
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
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. 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.
Interventions
BIOLOGICALlumiliximab
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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: 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
Countries
United States
Outcome results
None listed