Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have refractory or relapsed primary CNS lymphoma.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)|
- Radiographic Response [ Time Frame: 1 month, 2 months and then q3months ] [ Designated as safety issue: No ]it at any time point patient progresses no more scans are required, patient is off study
- Progression-free Survival [ Time Frame: pt had MRI q3months ] [ Designated as safety issue: No ]pt had MRI every 3 months
- Overall Survival [ Time Frame: 47 months ] [ Designated as safety issue: No ]survival was evaluated q 2months
- Toxicity [ Time Frame: 8 weeks - 2 cycles ] [ Designated as safety issue: Yes ]patients only received drug for 8 weeks
|Study Start Date:||May 2004|
|Study Completion Date:||June 2010|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Experimental: Rituximab monotherapy
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
- Determine the radiographic response proportion in patients with refractory or recurrent primary CNS lymphoma treated with rituximab.
- Determine the progression-free and overall survival of patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of rituximab off study at the discretion of the treating physician.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 5-9 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00072449
|United States, Alabama|
|Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida|
|Tampa, Florida, United States, 33612-9497|
|United States, Georgia|
|Winship Cancer Institute of Emory University|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Josephine Ford Cancer Center at Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Study Chair:||Tracy Batchelor, MD, MPH||Massachusetts General Hospital|