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Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

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ClinicalTrials.gov Identifier: NCT00072449
Recruitment Status : Terminated (slow accrual and lack of resources and priority due to combining 2 consortia)
First Posted : November 6, 2003
Results First Posted : August 28, 2013
Last Update Posted : August 28, 2013
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
Intervention Biological: rituximab
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab Monotherapy
Hide Arm/Group Description Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Rituximab Monotherapy
Hide Arm/Group Description Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
age, years Number Analyzed 12 participants
64
(31 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
5
  41.7%
Male
7
  58.3%
Karnofsky Performance Status Scale   [1] 
Median (Full Range)
Unit of measure:  Score
Number Analyzed 12 participants
85
(60 to 100)
[1]
Measure Description: 100 normal no complaints no disease 90 capable of normal activity few symptoms/disease 80 normal activity with some difficulty some symptoms or signs 70 caring for self not capable of normal activity or 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 and help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures or treatment 10 moribund rapidly progressive fatal disease processes 0 death
Mini-Mental State Examination (MMSE)   [1] 
Median (Full Range)
Unit of measure:  Score
Number Analyzed 12 participants
29
(18 to 30)
[1]
Measure Description: The mini–mental state examination (MMSE) is a 30-point questionnaire test used to screen for cognitive impairment. Commonly used to screen for dementia. It is also used to estimate the severity of cognitive impairment and to follow the course of cognitive changes in an individual over time. The MMSE test includes simple questions and problems in a number of areas: the time and place of the test, repeating lists of words, arithmetic such as the serial sevens, language use and comprehension, and basic motor skills. The Higher your score, the higher your function.
1.Primary Outcome
Title Radiographic Response
Hide Description it at any time point patient progresses no more scans are required, patient is off study
Time Frame 1 month, 2 months and then q3months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Monotherapy
Hide Arm/Group Description:
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
4
2.Secondary Outcome
Title Progression-free Survival
Hide Description pt had MRI every 3 months
Time Frame pt had MRI q3months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Monotherapy
Hide Arm/Group Description:
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
Overall Number of Participants Analyzed 12
Median (95% Confidence Interval)
Unit of Measure: days
57
(29 to 175)
3.Secondary Outcome
Title Overall Survival
Hide Description survival was evaluated q 2months
Time Frame 47 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Monotherapy
Hide Arm/Group Description:
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
Overall Number of Participants Analyzed 12
Median (95% Confidence Interval)
Unit of Measure: months
20.9
(2.9 to 47)
4.Secondary Outcome
Title Toxicity
Hide Description patients only received drug for 8 weeks
Time Frame 8 weeks - 2 cycles
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Monotherapy
Hide Arm/Group Description:
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: related episodes
4
Time Frame While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Adverse Event Reporting Description Note that not all AEs are related to treatment
 
Arm/Group Title Rituximab Monotherapy
Hide Arm/Group Description Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
All-Cause Mortality
Rituximab Monotherapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab Monotherapy
Affected / at Risk (%) # Events
Total   1/12 (8.33%)    
Infections and infestations   
infection-sepsis  1  1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rituximab Monotherapy
Affected / at Risk (%) # Events
Total   12/12 (100.00%)    
Blood and lymphatic system disorders   
white blood count  1  2/12 (16.67%)  8
Cardiac disorders   
Palpitations  1  1/12 (8.33%)  1
Ear and labyrinth disorders   
tinnitus  1  1/12 (8.33%)  1
Endocrine disorders   
Adrenal insufficiency  1  1/12 (8.33%)  1
Eye disorders   
Neuropathy: cranial - CN II Vision  1  1/12 (8.33%)  1
Ophthalmoplegia/diplopia (double vision)  1  1/12 (8.33%)  1
vision blurred  1  3/12 (25.00%)  3
Gastrointestinal disorders   
Colitis  1  1/12 (8.33%)  1
Constipation  1  2/12 (16.67%)  2
Diarrhea  1  1/12 (8.33%)  1
Gastrointestinal-other - mouth sores  1  1/12 (8.33%)  1
Nausea  1  2/12 (16.67%)  2
Pain - Abdomen NOS  1  1/12 (8.33%)  1
vomiting  1  2/12 (16.67%)  2
General disorders   
"Constitutional Symptoms - Other (Specify, cold  1  1/12 (8.33%)  1
Edema: limb  1  4/12 (33.33%)  6
"Fatigue (asthenia, lethargy, malaise)"  1  9/12 (75.00%)  9
"Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)"  1  1/12 (8.33%)  1
Rigors/chills  1  3/12 (25.00%)  3
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  1/12 (8.33%)  1
Infections and infestations   
"Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)"  1  1/12 (8.33%)  1
"Infection - Other (Specify, __)" - oral thrush  1  1/12 (8.33%)  1
"Infection - Other (Specify, __)" - shingles  1  1/12 (8.33%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)  1  1/12 (8.33%)  1
platelets  1  4/12 (33.33%)  8
aspartate aminotransferase SGOT  1  3/12 (25.00%)  3
Injury, poisoning and procedural complications   
Pain - Back  1  1/12 (8.33%)  1
Investigations   
Platelets  1  1/12 (8.33%)  1
Alkaline phosphatase  1  2/12 (16.67%)  2
Creatinine  1  1/12 (8.33%)  1
hemoglobin  1  6/12 (50.00%)  21
alanine aminotransferase SGPT  1  3/12 (25.00%)  5
total bilirubin  1  1/12 (8.33%)  1
Metabolism and nutrition disorders   
Anorexia  1  2/12 (16.67%)  2
Dehydration  1  1/12 (8.33%)  1
"Phosphate, serum-low (hypophosphatemia)"  1  1/12 (8.33%)  1
Hyponatremia  1  1/12 (8.33%)  1
Hyperglycemia  1  9/12 (75.00%)  13
Hyperkalemia  1  1/12 (8.33%)  1
Hypocalcemia  1  2/12 (16.67%)  2
Hypokalemia  1  1/12 (8.33%)  1
Hypomagnesemia  1  2/12 (16.67%)  2
Hyponatremia  1  4/12 (33.33%)  9
Musculoskeletal and connective tissue disorders   
"Muscle weakness, generalized or specific area (not due to neuropathy) - Left-sided"  1  4/12 (33.33%)  6
Pain - Extremity-limb  1  1/12 (8.33%)  1
Pain - Miuscle  1  2/12 (16.67%)  2
Nervous system disorders   
Ataxia (incoordination)  1  1/12 (8.33%)  1
Dizziness  1  2/12 (16.67%)  2
Memory impairment  1  1/12 (8.33%)  1
Neuropathy: motor  1  2/12 (16.67%)  2
Neuropathy: sensory  1  2/12 (16.67%)  3
Pain - Head/headache  1  4/12 (33.33%)  4
seizure  1  1/12 (8.33%)  1
somnolence  1  1/12 (8.33%)  1
speech impairment  1  2/12 (16.67%)  2
tremor  1  1/12 (8.33%)  1
Psychiatric disorders   
Confusion  1  6/12 (50.00%)  7
Mood alteration - Anxiety  1  3/12 (25.00%)  3
Mood alteration - Depression  1  1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/12 (8.33%)  1
Dyspnea (shortness of breath)  1  2/12 (16.67%)  2
"Pulmonary/Upper Respiratory - Other (Specify, __)"  1 [1]  1/12 (8.33%)  1
Skin and subcutaneous tissue disorders   
Dry skin  1  1/12 (8.33%)  1
Pruritus/itching  1  2/12 (16.67%)  2
Rash/desquamation  1  1/12 (8.33%)  1
Vascular disorders   
Hypotension  1  3/12 (25.00%)  3
thrombosis  1 [2]  1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
diminished breath sounds
[2]
RLE DVT
Study terminated early due to slow accrual and lack of resources and priority due to NCI mandate of combining two consortia. Unable to fully analyze the data, or objectives, not enough patients. Not able to do statistics
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: Dr. Stuart A Grossman
Organization: Johns Hopkins University
Phone: 410-955-3657
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00072449     History of Changes
Other Study ID Numbers: NABTT-2201 CDR0000339737
U01CA062475 ( U.S. NIH Grant/Contract )
NABTT-2201
First Submitted: November 4, 2003
First Posted: November 6, 2003
Results First Submitted: June 14, 2013
Results First Posted: August 28, 2013
Last Update Posted: August 28, 2013