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Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00004889
Collaborator
Genentech, Inc. (Industry)
8
Enrollment
8
Locations
1
Arm
67
Duration (Months)
1
Patient Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have Waldenstrom's macroglobulinemia.

Condition or Disease Intervention/Treatment Phase
  • Biological: rituximab
 Phase 2

Detailed Description

OBJECTIVES: I. Determine the objective response, time to treatment failure, and toxicity in patients with Waldenstrom's macroglobulinemia treated with rituximab. II. Correlate expression and changes in expression of CD20 on patient plasma cells and B-cells with clinical responses.

OUTLINE: This is a multicenter study. Patients receive rituximab IV weekly for 4 weeks. Treatment may be repeated 2 months later in patients with stable disease, partial response, or complete response. Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 12-25 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Rituximab (Rituxan, Mabthera) in Waldenstrom's Macroglobulinemia
Study Start Date :
Dec 1, 1999
Actual Primary Completion Date :
Jan 1, 2002
Actual Study Completion Date :
Jul 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rituxan

375 mg/m2 given as an intravenous (IV) infusion once weekly for four doses (days 1, 8, 15, and 22). For purposes of this study 4 weekly courses will constitute one cycle of therapy.

Biological: rituximab
375 mg/m2 given as an intravenous (IV) infusion once weekly for four doses (days 1, 8, 15, and 22). For purposes of this study 4 weekly courses will constitute one cycle of therapy.
Other Names:
  • Rituxan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Response (delay in disease progression or timing of disease progression) [24 weeks]

      Define objective response (delay in disease progression or timing of disease progression), time to treatment failure, and toxicity for single agent Rituxan therapy in Waldenstrom's macroglobulinemia patients

    Secondary Outcome Measures

    1. Expression of CD20 [24 weeks]

      To correlate expression and changes in expression of CD20 on waldenstrom's macroglobulinemia patient plasma cells and B-cells with clinical responses.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Waldenstrom's Macroglobulinemia requiring therapy who have received no more than 2 prior courses of therapy; previously untreated patients with slowly progressive WM if the patient can reasonably be expected to not require chemotherapy or steroid therapy for 90 days

    • CD20 positive tumor cells

    • Presence of monoclonal paraprotein

    • Minimum IgM level > 2 times the upper limit of normal

    • Adequate organ function: ANC>1000/uL; PLT > 25000/uL; serum creatinine < 2.5; serum total bilirubin and SGOT < 2.5 times the upper limit of normal

    • 18 years and older

    • Life expectancy of 6 months or greater

    • ECOG performance status of 0-2

    • Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for 6 months after completion of treatment

    Exclusion Criteria:

    • Chemotherapy, steroid therapy, or radiation therapy within 30 days of study entry

    • Patients who are pregnant

    • Serious co-morbid disease

    • Uncontrolled bacterial, fungal, or viral infection

    • Active second malignancy

    • Individuals who cannot provide informed written consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Center and Beckman Research Institute, City of Hope Duarte California United States 91010-3000
    2 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    3 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
    4 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    5 Brigham and Women's Hospital Boston Massachusetts United States 02115
    6 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    7 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    8 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center
    • Genentech, Inc.

    Investigators

    • Principal Investigator: Christos E. Emmanouilides, MD, Jonsson Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004889
    Other Study ID Numbers:
    • CDR0000067565
    • UCLA-9909016
    • NCI-G00-1709
    First Posted:
    Feb 12, 2004
    Last Update Posted:
    Aug 3, 2020
    Last Verified:
    Jul 1, 2012
    Keywords provided by , ,
    Waldenstrom macroglobulinemia
    Additional relevant MeSH terms:
    Waldenstrom Macroglobulinemia
    Rituximab

    Study Results

    No Results Posted as of Aug 3, 2020