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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 30, 2014