Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia

Phase 1CompletedNCT00019032

National Cancer Institute (NCI)25 enrolled

Overview

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-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 chronic lymphocytic leukemia.

OBJECTIVES: * Evaluate the toxicity of murine monoclonal antibody Mik-beta-1 (MOAB Mik-beta-1) in patients with T-cell large granular lymphocytic leukemia associated with granulocytopenia, anemia, or thrombocytopenia. * Determine the clinical response in patients treated with this drug. * Assess the effect of this drug on the number of circulating CD3+, CD8+ expressing granular lymphocytes and the number of polymorphonuclear leukocytes, red blood cells, and platelets in this patient population. * Monitor patients for the time course of decline in circulating infused MOAB Mik-beta-1 and for the production of human antibodies to IV infused murine MOAB Mik-beta-1. OUTLINE: This is a dose-escalation study. Patients receive monoclonal antibody Mik-beta-1 (MOAB Mik-beta-1) IV over 2 hours on days 1, 4, 7, and 10. Patients achieving a complete response (CR) or partial response (PR) may receive 1 additional course beginning no sooner than 4 weeks after completion of the first course, in the absence of antibodies to MOAB Mik-beta-1. Treatment continues in the absence of disease progression, unacceptable toxicity, or severe allergic reaction. Cohorts of 3-6 patients receive escalating doses of MOAB Mik-beta-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 6-10 days and at 4-6 weeks after therapy. Patients with a PR or CR may be followed every 6 months for 2 years or until relapse. All patients are followed for survival. PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Leukemia

Interventions

monoclonal antibody Mik-beta-1BIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed T-cell large granular lymphocytic (T-LGL) leukemia associated with clinically significant hematocytopenia demonstrated by one of the following values while off growth factor support: * Absolute neutrophil count less than 1,000/mm\^3 * Hemoglobin less than 8 g/dL * Platelet count less than 50,000/mm\^3 * Clinically evaluable disease with peripheral blood T-LGL leukemia cells expressing the CD3+, CD8+ phenotype detectable by FACS * Monoclonal T-cell population in peripheral blood (circulating mononuclear cells) demonstrated by TCR beta or gamma chain gene rearrangement PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 50-100% Life expectancy: * More than 2 months Hematopoietic: * See Disease Characteristics * No active major bleeding episode within the past 4 weeks Hepatic: * Direct bilirubin less than 1.5 mg/dL Renal: * Creatinine less than 2.0 mg/dL Other: * No concurrent serious active infection * Patients with fever without apparent site of infection may begin study while on antibiotics as long as the following are true: * No pathogenic organism in culture * Afebrile (maximum temperature less than 38°C) for at least 5 days * HIV negative * No other primary cancer other than basal cell skin cancer * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior interferon * Concurrent filgrastim (G-CSF), sargramostim (GM-CSF), interleukin-11, or similar sustained-release/long-acting product (e.g., pegylated G-CSF) allowed if dose established at least 4 weeks prior to study participation * No concurrent interferon Chemotherapy: * At least 4 weeks since prior chemotherapy * No concurrent chemotherapy Endocrine therapy: * Concurrent corticosteroids allowed if dose established at least 3 weeks prior to study participation Radiotherapy: * Not specified Surgery: * Not specified Other: * At least 1 week since completion of prior antibiotic regimen for serious infectious episode * No other concurrent investigational drugs

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Data from ClinicalTrials.gov

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