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Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia

Primary Purpose

Lymphoma

Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
alemtuzumab
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Waldenström macroglobulinemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA
  • Rocky Mountain Cancer Centers - Denver Midtown
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Massachusetts General Hospital Cancer Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Beth Israel Deaconess Medical Center
  • Long Island Jewish Medical Center
  • Herbert Irving Comprehensive Cancer Center at Columbia University
  • Cleveland Clinic Taussig Cancer Center
  • Peter MacCallum Cancer Centre
  • McMaster Children's Hospital at Hamilton Health Sciences
  • Princess Margaret Hospital
  • Centre Hospitalier Lens
  • Saint Bartholomew's Hospital

Outcomes

Primary Outcome Measures

Objective response
Time to treatment failure
Toxicity

Secondary Outcome Measures

Full Information

First Posted
April 7, 2004
Last Updated
January 7, 2013
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00081068
Brief Title
Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia
Official Title
Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Withdrawn
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Waldenström macroglobulinemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
alemtuzumab
Primary Outcome Measure Information:
Title
Objective response
Title
Time to treatment failure
Title
Toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Gansert, MD, PhD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Denver Midtown
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Peter MacCallum Cancer Centre
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
McMaster Children's Hospital at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
ON L8N 3Z5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C1
Country
Canada
Facility Name
Centre Hospitalier Lens
City
Lens
ZIP/Postal Code
62307
Country
France
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom

12. IPD Sharing Statement

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Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia

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