Clinical trial NCT00004889: Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia
Official title: Phase II Study of Rituximab (Rituxan, Mabthera) in Waldenstrom's Macroglobulinemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: Waldenstrom macroglobulinemia
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2004-02-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Response (delay in disease progression or timing of disease progression)
timeFrame: 24 weeks
Secondary outcomes:
measure: Expression of CD20
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Cancer Center and Beckman Research Institute, City of Hope
state: California
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Christos E. Emmanouilides, MD
role: PRINCIPAL_INVESTIGATOR
References: