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Study of High-Dose Rituximab With Temozolomide as Treatment for Primary Central Nervous System (CNS) Lymphoma

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ClinicalTrials.gov Identifier: NCT02113007
Recruitment Status : Terminated (Closed early due to slow accrual.)
First Posted : April 14, 2014
Results First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Central Nervous System Lymphoma
Intervention Drug: Rituximab plus Temozolomide
Enrollment 2
Recruitment Details In August 2015, 2 patients with confirmed primary central nervous system (CNS) lymphoma were enrolled in the trial. Only one (of 4) investigational sites in the U.S accrued patients. Due to slow enrollment, the study was terminated in February 2016.
Pre-assignment Details  
Arm/Group Title Rituximab Plus Temozolomide
Hide Arm/Group Description

Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5

Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles.

Period Title: Overall Study
Started 2
Completed 0
Not Completed 2
Reason Not Completed
Progressive disease             2
Arm/Group Title Rituximab Plus Temozolomide
Hide Arm/Group Description

Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5

Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles.

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 2 participants
2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Overall Response Rate
Hide Description Patients will be assessed for response by MRI of brain and/or spine after 4 cycles (8 weeks) of treatment according to Response Criteria for Primary CNS Lymphoma. Patients with stable disease or better (CR or PR) will continue treatment for 12 cycles (24 weeks). Complete Response (CR)=no contrast enhancement, normal eye exam. Partial Response (PR)=50 percent decrease in tumor enhancement, minor retinal pigment epithelium abnormality in eye exam. Stable disease (SD)= a change in lesion size that is neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for progressive disease.
Time Frame approximately 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study closed early due to slow accrual. This outcome measure was not reached.
Arm/Group Title Rituximab Plus Temozolomide
Hide Arm/Group Description:

Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5

Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Six and twelve-month CNS progression-free survival rate.
Time Frame 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study closed early due to slow accrual; outcome measure not reached.
Arm/Group Title Rituximab Plus Temozolomide
Hide Arm/Group Description:

Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5

Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events as a Measure of Safety.
Hide Description Patients in the safety lead-in part of the study were monitored for up to 2 treatment cycles (4 weeks) to assure there were no unexpected or prohibitive toxicities. A non-serious adverse event is any untoward medical occurrence. A serious adverse event (SAE) is an event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage. Specific AE and SAE terms are provided in the Adverse event module.
Time Frame up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Plus Temozolomide
Hide Arm/Group Description:

Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5

Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles.

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
Adverse Events 2
Serious Adverse Events 1
Time Frame Adverse events and serious adverse events were collected for up to 4 weeks during the safety lead-in part of the study. The study closed early due to slow accrual.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab Plus Temozolomide
Hide Arm/Group Description

Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5

Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles.

All-Cause Mortality
Rituximab Plus Temozolomide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab Plus Temozolomide
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Metabolism and nutrition disorders   
Hyponatraemia * 1  1/2 (50.00%)  1
Hypoglycemia * 1  1/2 (50.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 4.03
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rituximab Plus Temozolomide
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Gastrointestinal disorders   
Flatulence * 1  1/2 (50.00%) 
General disorders   
Gait disturbance * 1  1/2 (50.00%) 
Fatigue * 1  2/2 (100.00%) 
Metabolism and nutrition disorders   
Hypoalbuminemia * 1  1/2 (50.00%) 
Nervous system disorders   
Hypersomnia * 1  1/2 (50.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 4.03
Two (2) subjects were enrolled in the safety lead-in part of the study. The study closed early due to slow accrual.
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 sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Charles H. Davis, RAC
Organization: Sarah Cannon Development Innovations
Phone: 615-524-4341
EMail: charles.davis2@scri-innovations.com
Layout table for additonal information
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT02113007     History of Changes
Other Study ID Numbers: SCRI CNS 20
First Submitted: April 10, 2014
First Posted: April 14, 2014
Results First Submitted: December 14, 2016
Results First Posted: February 7, 2017
Last Update Posted: February 7, 2017