Monoclonal Antibody in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT ID: NCT00058396

Last Updated: 2013-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31

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.

Conditions

Leukemia; Lymphoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

lumiliximab

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Mark Adam Weiss, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

MSKCC-02096

Identifier Type: -

Identifier Source: secondary_id

CDR0000288828

Identifier Type: REGISTRY

Identifier Source: secondary_id

IDEC-152-20

Identifier Type: -

Identifier Source: org_study_id