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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00058396
First received: April 7, 2003
Last updated: May 29, 2013
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Biological: lumiliximab
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study Of IDEC-152 (Anti-CD23 Monoclonal Antibody) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2002
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058396

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Mark Adam Weiss, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00058396     History of Changes
Other Study ID Numbers: IDEC-152-20, MSKCC-02096, CDR0000288828
Study First Received: April 7, 2003
Last Updated: May 29, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
noncontiguous stage II small lymphocytic lymphoma
recurrent small lymphocytic lymphoma
stage I small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage IV small lymphocytic lymphoma
contiguous stage II small lymphocytic lymphoma

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014