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Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

This study has been terminated.
(slow accrual and lack of resources and priority due to combining 2 consortia)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center Identifier:
First received: November 4, 2003
Last updated: June 14, 2013
Last verified: June 2013
Results First Received: June 14, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Intervention: Biological: rituximab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Rituximab Monotherapy Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks

Participant Flow:   Overall Study
    Rituximab Monotherapy

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Rituximab Monotherapy Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks

Baseline Measures
   Rituximab Monotherapy 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
age, years   64 
 (31 to 81) 
[Units: Participants]
Female   5 
Male   7 
Karnofsky Performance Status Scale [1] 
[Units: Score]
Median (Full Range)
 (60 to 100) 
[1] 100 normal no complaints no disease 90 capable of normal activity few symptoms/disease 80 normal activity with some difficulty some symptoms or signs 70 caring for self not capable of normal activity or work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care and help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures or treatment 10 moribund rapidly progressive fatal disease processes 0 death
Mini-Mental State Examination (MMSE) [1] 
[Units: Score]
Median (Full Range)
 (18 to 30) 
[1] The mini–mental state examination (MMSE) is a 30-point questionnaire test used to screen for cognitive impairment. Commonly used to screen for dementia. It is also used to estimate the severity of cognitive impairment and to follow the course of cognitive changes in an individual over time. The MMSE test includes simple questions and problems in a number of areas: the time and place of the test, repeating lists of words, arithmetic such as the serial sevens, language use and comprehension, and basic motor skills. The Higher your score, the higher your function.

  Outcome Measures
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1.  Primary:   Radiographic Response   [ Time Frame: 1 month, 2 months and then q3months ]

2.  Secondary:   Progression-free Survival   [ Time Frame: pt had MRI q3months ]

3.  Secondary:   Overall Survival   [ Time Frame: 47 months ]

4.  Secondary:   Toxicity   [ Time Frame: 8 weeks - 2 cycles ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study terminated early due to slow accrual and lack of resources and priority due to NCI mandate of combining two consortia. Unable to fully analyze the data, or objectives, not enough patients. Not able to do statistics

  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Stuart A Grossman
Organization: Johns Hopkins University
phone: 410-955-3657


Responsible Party: Sidney Kimmel Comprehensive Cancer Center Identifier: NCT00072449     History of Changes
Other Study ID Numbers: NABTT-2201 CDR0000339737
U01CA062475 ( US NIH Grant/Contract Award Number )
Study First Received: November 4, 2003
Results First Received: June 14, 2013
Last Updated: June 14, 2013