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Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00248534
Recruitment Status : Terminated (slow accrual/lack of resources/low priority due to combining 2 consortia)
First Posted : November 4, 2005
Results First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Interventions Biological: rituximab
Drug: methylprednisolone
Drug: temozolomide
Enrollment 16
Recruitment Details patients enrolled from 2005 through 2008. Patients enrolled in an outpatient multi-institutional clinics
Pre-assignment Details  
Arm/Group Title IV Rituximab
Hide Arm/Group Description

IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.

Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide [TMZ] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression

rituximab: given IV days 1,8, 15 and 22

methylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)

temozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles

Period Title: Overall Study
Started 16
Completed 16
Not Completed 0
Arm/Group Title IV Rituximab
Hide Arm/Group Description

IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.

Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide [TMZ] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression

rituximab: given IV days 1,8, 15 and 22

methylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)

temozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants
63
(42 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
12
  75.0%
Male
4
  25.0%
Karnofsky Performance Status Scale   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 16 participants
90
(60 to 100)
[1]
Measure Description: Higher score better 100 normal no complaints/disease 90 capable normal activity few symptoms/disease 80 normal activity, some difficulty some symptoms/signs 70 caring for self not capable normal activity/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/help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures/treatment 10 moribund rapidly progressive fatal disease processes 0 death
1.Primary Outcome
Title Percentage of Participants With Objective Response
Hide Description Objective response rate of the combination of Rituximab and TMZ
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients were not evaluable, one died prematurely and the other withdrew consent before the first scan (during induction cycle)
Arm/Group Title IV Rituximab
Hide Arm/Group Description:

IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.

Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide [TMZ] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression

rituximab: given IV days 1,8, 15 and 22

methylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)

temozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles

Overall Number of Participants Analyzed 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
14
(2 to 43)
2.Secondary Outcome
Title Number of Participants Alive at 3 Years
Hide Description The intent was to measure Median Overall Survival at 3 years, however only one participant was analyzable at this time point. Therefore, the number of participants who survived is reported instead.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient died prematurely, one patient withdrew consent before first scan (during induction), 13 patients came off study due to progression of disease.
Arm/Group Title IV Rituximab
Hide Arm/Group Description:

IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.

Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide [TMZ] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression

rituximab: given IV days 1,8, 15 and 22

methylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)

temozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles

Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
3.Secondary Outcome
Title 1 Year Overall Survival Rate
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Rituximab
Hide Arm/Group Description:

IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.

Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide [TMZ] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression

rituximab: given IV days 1,8, 15 and 22

methylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)

temozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles

Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
71
(40 to 88)
4.Secondary Outcome
Title 6-month Progression-free Survival
Hide Description

Scan at 6 months

Complete response: Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks

Partial response: Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks.

Progressive disease: Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.

Stable disease: Clinical status and MRI does not qualify for complete response, partial response or progression

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Rituximab
Hide Arm/Group Description:

IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.

Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide [TMZ] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression

rituximab: given IV days 1,8, 15 and 22

methylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)

temozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles

Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13
(2 to 35)
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Rituximab
Hide Arm/Group Description

IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.

Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide [TMZ] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression

rituximab: given IV days 1,8, 15 and 22

methylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)

temozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles

All-Cause Mortality
IV Rituximab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IV Rituximab
Affected / at Risk (%) # Events
Total   0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV Rituximab
Affected / at Risk (%) # Events
Total   14/16 (87.50%)    
Blood and lymphatic system disorders   
hematotoxicity * 1  8/16 (50.00%)  8
General disorders   
fatigue * 1  3/16 (18.75%)  3
Investigations   
liver enzyme elevation * 1  2/16 (12.50%)  2
Skin and subcutaneous tissue disorders   
skin rash * 1  1/16 (6.25%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
slow accrual, preliminary analysis suggesting futility and combining of consortia, trial closed early
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
Layout table for Results Point of Contact information
Name/Title: Lauren Abrey, MD
Organization: North American Brain Tumor Consortium
Phone: 410-955-3657
EMail: jfisher@jhmi.edu
Publications of Results:
Nayak L, Abrey LE, Drappatz J, et al.: Multicenter phase II trial of temozolomide (TMZ) and rituximab (RIT) for recurrent primary CNS lymphoma (PCNSL): North American Brain Tumor Consortium (NABTC) study 05-01. [Abstract] J Clin Oncol 29 (Suppl 15): A-2039, 2011.
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00248534     History of Changes
Other Study ID Numbers: NABTC05-01
NABTC-05-01
CDR0000445289 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2012-02673 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
U01CA062399 ( U.S. NIH Grant/Contract )
First Submitted: November 3, 2005
First Posted: November 4, 2005
Results First Submitted: October 14, 2016
Results First Posted: September 3, 2018
Last Update Posted: September 3, 2018