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Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma

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ClinicalTrials.gov Identifier: NCT00068250
Recruitment Status : Completed
First Posted : September 11, 2003
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Brain and Central Nervous System Tumors
Lymphoma
Interventions: Drug: rituximab
Drug: methotrexate
Drug: temozolomide 100 mg/m^2
Drug: temozolomide 150 mg/m^2
Drug: temozolomide 200 mg/m^2
Radiation: radiation therapy
Drug: post-radiation therapy temozolomide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Phase I: Temozolomide 100 mg Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
Phase I: Temozolomide 150 mg Rituximab, methotrexate, temozolomide 150 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
Phase I: Temozolomide 200 mg Rituximab, methotrexate, temozolomide 200 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
Phase II: Temozolomide 100 mg Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.

Participant Flow for 3 periods

Period 1:   Phase I: Dose Level 1
    Phase I: Temozolomide 100 mg   Phase I: Temozolomide 150 mg   Phase I: Temozolomide 200 mg   Phase II: Temozolomide 100 mg
STARTED   6   0   0   0 
COMPLETED   6 [1]   0   0   0 
NOT COMPLETED   0   0   0   0 
[1] Subjects with data available for the primary analysis are considered to have completed the study.

Period 2:   Phase I: Dose Level 2
    Phase I: Temozolomide 100 mg   Phase I: Temozolomide 150 mg   Phase I: Temozolomide 200 mg   Phase II: Temozolomide 100 mg
STARTED   0   7   0   0 
COMPLETED   0   6 [1]   0   0 
NOT COMPLETED   0   1   0   0 
Protocol Violation                0                1                0                0 
[1] Subjects with data available for the primary analysis are considered to have completed the study.

Period 3:   Phase II: Dose Level 2
    Phase I: Temozolomide 100 mg   Phase I: Temozolomide 150 mg   Phase I: Temozolomide 200 mg   Phase II: Temozolomide 100 mg
STARTED   0   0   0   47 
COMPLETED   0   0   0   47 [1] 
NOT COMPLETED   0   0   0   0 
[1] Subjects with data available for the primary analysis are considered to have completed the study.



  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 started study treatment

Reporting Groups
  Description
Phase I: Temozolomide 100 mg Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
Phase I: Temozolomide 150 mg Rituximab, methotrexate, temozolomide 150 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
Phase II: Temozolomide 100 mg Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
Total Total of all reporting groups

Baseline Measures
   Phase I: Temozolomide 100 mg   Phase I: Temozolomide 150 mg   Phase II: Temozolomide 100 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   47   59 
Age 
[Units: Years]
Median (Full Range)
 57 
 (43 to 70) 
 62 
 (47 to 72) 
 57 
 (24 to 73) 
 57 
 (24 to 73) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      4  66.7%      2  33.3%      24  51.1%      30  50.8% 
Male      2  33.3%      4  66.7%      23  48.9%      29  49.2% 


  Outcome Measures

1.  Primary:   Number of Phase I Participants Experiencing Toxicity   [ Time Frame: From start of treatment to 10 weeks if radiation therapy received, to 15 weeks if not. ]

2.  Primary:   Phase II: Overall Survival Rate at 2 Years (Including Phase I Patients at Same Dose)   [ Time Frame: Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years. ]

3.  Secondary:   Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (Including Phase I Patients at Same Dose)   [ Time Frame: From start of treatment to 10 weeks if RT received, to 15 weeks if not. ]

4.  Secondary:   Phase II: Progression-free Survival (Including Phase I Patients at Same Dose)   [ Time Frame: Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years. ]


  Serious Adverse Events


  Other Adverse Events


  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
The 200 mg/m^2 treatment arm in the phase I component of the study did not open. Outcome measures are categorized as the phase I or phase II study component, but phase I patients at corresponding dose level are included in the phase II analyses.


  More Information

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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org


Publications of Results:

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00068250     History of Changes
Other Study ID Numbers: RTOG-0227
CDR0000301563
First Submitted: September 10, 2003
First Posted: September 11, 2003
Results First Submitted: December 14, 2017
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018