Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00072449|
Recruitment Status : Terminated (slow accrual and lack of resources and priority due to combining 2 consortia)
First Posted : November 6, 2003
Results First Posted : August 28, 2013
Last Update Posted : August 28, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||June 2010|
Experimental: Rituximab monotherapy
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
- Radiographic Response [ Time Frame: 1 month, 2 months and then q3months ]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 ]pt had MRI every 3 months
- Overall Survival [ Time Frame: 47 months ]survival was evaluated q 2months
- Toxicity [ Time Frame: 8 weeks - 2 cycles ]patients only received drug for 8 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|