Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia

NCT ID: NCT00019032

Last Updated: 2015-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Leukemia

Study Design

• Primary Study Purpose: TREATMENT

Interventions

monoclonal antibody Mik-beta-1

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Thomas A. Waldmann, MD

Role: STUDY_CHAIR

NCI - Metabolism Branch;MET

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

NCI-95-C-0054K

Identifier Type: -

Identifier Source: secondary_id

CDR0000064038

Identifier Type: -

Identifier Source: org_study_id

NCT00001425

Identifier Type: -

Identifier Source: nct_alias