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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00072449
First Posted: November 6, 2003
Last Update Posted: August 28, 2013
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
Results First Submitted: June 14, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
  Description
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
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 



  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.
No text entered.

Reporting Groups
  Description
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]
 12 
Age 
[Units: Years]
Median (Full Range)
 
age, years   64 
 (31 to 81) 
Gender 
[Units: Participants]
 
Female   5 
Male   7 
Karnofsky Performance Status Scale [1] 
[Units: Score]
Median (Full Range)
 85 
 (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)
 29 
 (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 ]
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Measure Type Primary
Measure Title Radiographic Response
Measure Description it at any time point patient progresses no more scans are required, patient is off study
Time Frame 1 month, 2 months and then q3months  

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.
No text entered.

Reporting Groups
  Description
Rituximab Monotherapy Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks

Measured Values
   Rituximab Monotherapy 
Participants Analyzed 
[Units: Participants]
 11 
Radiographic Response 
[Units: Participants]
 4 

No statistical analysis provided for Radiographic Response



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