Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia
NCT ID: NCT00081068
Last Updated: 2013-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2004-01-31
Brief Summary
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PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstrom's macroglobulinemia.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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alemtuzumab
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Jonsson Comprehensive Cancer Center
OTHER
Principal Investigators
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Jennifer Gansert, MD, PhD
Role: STUDY_CHAIR
Jonsson Comprehensive Cancer Center
Locations
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Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Rocky Mountain Cancer Centers - Denver Midtown
Denver, Colorado, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Centre Hospitalier Lens
Lens, , France
Saint Bartholomew's Hospital
London, England, United Kingdom
Countries
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Other Identifiers
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UCLA-0309058
Identifier Type: -
Identifier Source: secondary_id
CDR0000358811
Identifier Type: -
Identifier Source: org_study_id
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