This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma

This study has been terminated.
(slow accrual)
Sponsor:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00335140
First received: June 7, 2006
Last updated: May 23, 2017
Last verified: May 2017
Results First Received: April 17, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Biological: Rituximab
Drug: Cytarabine
Drug: Dexamethasone
Drug: Leucovorin
Drug: Methotrexate
Drug: Procarbazine
Drug: Vincristine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from ECOG-ACRIN member institutions starting 12/21/2006. The study was suspended 2/24/2010 for interim analysis. After the interim analysis, it was determined that the goals of the study had been met and the study was closed on 4/12/2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rituximab + Standard Chemotherapy

rituximab

cytarabine

dexamethasone

leucovorin calcium

methotrexate

procarbazine hydrochloride

vincristine sulfate


Participant Flow:   Overall Study
    Rituximab + Standard Chemotherapy
STARTED   26 
Eligible   25 
Treated   25 
COMPLETED   25 
NOT COMPLETED   1 
Ineligible                1 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Eligible patients who began protocol therapy

Reporting Groups
  Description
Rituximab + Standard Chemotherapy

rituximab

cytarabine

dexamethasone

leucovorin calcium

methotrexate

procarbazine hydrochloride

vincristine sulfate


Baseline Measures
   Rituximab + Standard Chemotherapy 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age, Customized [1] 
[Units: Participants]
Count of Participants
 
Age   
Age < 60 years      15  60.0% 
Age ≥ 60 years      10  40.0% 
[1] Older or younger than 60
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  60.0% 
Male      10  40.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Race   
White      24  96.0% 
Asian      1   4.0% 
Region of Enrollment 
[Units: Participants]
 
United States   25 
ECOG Performance Status [1] 
[Units: Participants]
Count of Participants
 
    1   4.0% 
    15  60.0% 
    5  20.0% 
    4  16.0% 
[1]

0 = Fully active, able to carry on all pre-disease performance without restriction

  1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
  2. = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
  3. = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
  4. = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
Neurologic Function Status 
[Units: Participants]
Count of Participants
 
No symptoms      0   0.0% 
Minor symptoms      11  44.0% 
Moderate symptoms/fully active      5  20.0% 
Moderate symptoms/less than fully active      7  28.0% 
Severe neurologic symptoms      2   8.0% 
Cerebrovascular Disease 
[Units: Participants]
Count of Participants
 
Never      21  84.0% 
Symptomatic or on medication      4  16.0% 
Other Medical Problems at Baseline 
[Units: Participants]
Count of Participants
 
Never      9  36.0% 
Symptomatic or on medication      7  28.0% 
Past history of      7  28.0% 
Missing/unknown      2   8.0% 


  Outcome Measures

1.  Primary:   Complete Response Rate - Locally Reviewed   [ Time Frame: For the primary endpoint, complete response will be based on disease status at three weeks post the end of therapy (week 17). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: Lode Swinnen, MD
Organization: Johns Hopkins Cancer Center
phone: (410) 955-8603
e-mail: lswinne1@jhmi.edu



Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00335140     History of Changes
Other Study ID Numbers: CDR0000475776
ECOG-E1F05 ( Other Identifier: ECOG-ACRIN )
Study First Received: June 7, 2006
Results First Received: April 17, 2017
Last Updated: May 23, 2017