Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia

January 7, 2013 updated by: Jonsson Comprehensive Cancer Center

Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstrom's macroglobulinemia.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the objective response in patients with Waldenstrom's macroglobulinemia treated with alemtuzumab.
  • Determine the time to treatment failure in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive alemtuzumab IV over 2 hours on days 1, 3, and 5 of weeks 1-6 (course 1) in the absence of disease progression or unacceptable toxicity. Patients with a complete response undergo observation. Patients with stable disease or a minor or partial response receive an additional course of alemtuzumab, administered as in course 1, on weeks 7-12.

Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2

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

  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Peter MacCallum Cancer Centre
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, ON L8N 3Z5
        • McMaster Children's Hospital at Hamilton Health Sciences
      • Toronto, Ontario, Canada, M5G 2C1
        • Princess Margaret Hospital
  • France
      • Lens, France, 62307
        • Centre Hospitalier Lens
  • United Kingdom
    • England
      • London, England, United Kingdom, EC1A 7BE
        • Saint Bartholomew's Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers - Denver Midtown
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
    • New York
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig 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:

  • Diagnosis of Waldenstrom's macroglobulinemia (lymphoplasmacytic lymphoma)

    • Immunoglobulin (Ig) M, IgG, and IgA paraprotein
    • Measurable monoclonal paraprotein
  • Failed at least 1 prior first-line therapy (alkylator agent, nucleoside analogue, or rituximab)
  • CD52-positive tumor determined by either bone marrow immunohistochemistry or flow cytometry

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • Absolute neutrophil count ≥ 500/mm^3
  • Platelet count ≥ 25,000/mm^3

Hepatic

  • SGOT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 2.5 mg/dL (> 2.5 mg/dL allowed if due to disease)

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception during and for 6 months after study participation
  • No serious comorbid disease
  • No uncontrolled bacterial, fungal, or viral infection
  • No other active malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No prior alemtuzumab
  • More than 3 months since other prior monoclonal antibody therapy

Chemotherapy

  • See Disease Characteristics
  • More than 21 days since prior chemotherapy

Endocrine therapy

  • More than 21 days since prior steroid therapy

Radiotherapy

  • More than 21 days since prior radiotherapy

Surgery

  • Not specified

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Objective response
Toxicity
Time to treatment failure

Collaborators and Investigators

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

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Jennifer Gansert, MD, PhD, Jonsson Comprehensive Cancer Center

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

January 1, 2004

Study Registration Dates

First Submitted

April 7, 2004

First Submitted That Met QC Criteria

April 7, 2004

First Posted (ESTIMATE)

April 8, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 7, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000358811
  • UCLA-0309058

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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