Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Primary CNS Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier:
NCT00098774
First received: December 8, 2004
Last updated: September 11, 2014
Last verified: September 2014
Results First Received: June 26, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Biological: filgrastim
Biological: rituximab
Drug: cytarabine
Drug: etoposide
Drug: leucovorin calcium
Drug: methotrexate
Drug: temozolomide

  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
Between October 2004 and November 2009, 47 participants were recruited at 12 CALGB sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three participants were excluded from analysis because of failure to meet eligibility criteria or to receive protocol therapy.

Reporting Groups
  Description
Intensive Combination Chemo & Immunotherapy

Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11

Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16

Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11

Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)


Participant Flow:   Overall Study
    Intensive Combination Chemo & Immunotherapy  
STARTED     44  
COMPLETED     26  
NOT COMPLETED     18  
Adverse Event                 2  
Disease Progression                 9  
Withdrawal by Subject                 1  
Failed (to respond) during induction                 4  
Physician Decision                 2  



  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
Intensive Combination Chemo & Immunotherapy

Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11

Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16

Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11

Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)


Baseline Measures
    Intensive Combination Chemo & Immunotherapy  
Number of Participants  
[units: participants]
  44  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 12 to 76 )  
Gender  
[units: participants]
 
Female     23  
Male     21  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     2  
Native Hawaiian or Other Pacific Islander     2  
Black or African American     0  
White     40  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     44  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Response Rate After Remission Induction   [ Time Frame: 4 months ]

2.  Secondary:   4 Year Progression Free Rate   [ Time Frame: 4 years ]

3.  Secondary:   Change From Baseline in Mini-Mental Status Evaluation at 4 Months   [ Time Frame: Baseline & month 4 ]

4.  Secondary:   4 Year Overall Survival Rate   [ Time Frame: 4 years ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: James Rubenstein, MD, PhD
Organization: University of California, San Francisco
e-mail: jamesr@medicine.ucsf.edu


Publications of Results:

Responsible Party: Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier: NCT00098774     History of Changes
Other Study ID Numbers: CDR0000398106, U10CA031946, CALGB-50202
Study First Received: December 8, 2004
Results First Received: June 26, 2014
Last Updated: September 11, 2014
Health Authority: United States: Federal Government