Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00081068
First received: April 7, 2004
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Lymphoma
Biological: alemtuzumab
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Objective response [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: January 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00081068

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00081068     History of Changes
Other Study ID Numbers: CDR0000358811, UCLA-0309058
Study First Received: April 7, 2004
Last Updated: January 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Jonsson Comprehensive Cancer Center:
Waldenström macroglobulinemia

Additional relevant MeSH terms:
Lymphoma
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Alemtuzumab
Campath 1G
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014