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Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia
This study has been completed.
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00081068
  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
Drug: alemtuzumab
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Alemtuzumab Campath
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

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

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 ]

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
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
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
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, England
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

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000358811, UCLA-0309058
Study First Received: April 7, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00081068  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Waldenstrom macroglobulinemia

Study placed in the following topic categories:
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Hemorrhagic Disorders
Alemtuzumab
Waldenstrom macroglobulinemia
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009