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

Lymphoma Clinical Trial

Official title:

Phase I Study Of IDEC-152 (Anti-CD23 Monoclonal Antibody) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00058396
• Other study ID #: IDEC-152-20
• Secondary ID: MSKCC-02096CDR00
• Status: Completed
• Phase: Phase 1
• First received: April 7, 2003
• Last updated: May 29, 2013
• Start date: October 2002

Study information

• Verified date: December 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma

Intervention

Biological:
• lumiliximab

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,