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

May 29, 2013 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

April 7, 2003

First Submitted That Met QC Criteria

April 8, 2003

First Posted (Estimate)

April 9, 2003

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDEC-152-20
  • MSKCC-02096
  • CDR0000288828 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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