Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

This study has been terminated.
(slow accrual and lack of resources and priority due to combining 2 consortia)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00072449
First received: November 4, 2003
Last updated: June 14, 2013
Last verified: June 2013
Results First Received: June 14, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Intervention: Biological: rituximab

  Participant Flow
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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
Rituximab Monotherapy Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks

Participant Flow:   Overall Study
    Rituximab Monotherapy  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Rituximab Monotherapy Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks

Baseline Measures
    Rituximab Monotherapy  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Median ( Full Range )
 
age, years     64  
  ( 31 to 81 )  
Gender  
[units: participants]
 
Female     5  
Male     7  
Karnofsky Performance Status Scale [1]
[units: Score]
Median ( Full Range )
  85  
  ( 60 to 100 )  
Mini-Mental State Examination (MMSE) [2]
[units: Score]
Median ( Full Range )
  29  
  ( 18 to 30 )  
[1] 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
[2] 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.



  Outcome Measures
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1.  Primary:   Radiographic Response   [ Time Frame: 1 month, 2 months and then q3months ]

2.  Secondary:   Progression-free Survival   [ Time Frame: pt had MRI q3months ]

3.  Secondary:   Overall Survival   [ Time Frame: 47 months ]

4.  Secondary:   Toxicity   [ Time Frame: 8 weeks - 2 cycles ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Additional Description Note that not all AEs are related to treatment

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Rituximab Monotherapy Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks

Other Adverse Events
    Rituximab Monotherapy  
Total, other (not including serious) adverse events    
# participants affected / at risk     12/12  
Blood and lymphatic system disorders    
white blood count † 1  
# participants affected / at risk     2/12 (16.67%)  
# events     8  
Cardiac disorders    
Palpitations † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Ear and labyrinth disorders    
tinnitus † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Endocrine disorders    
Adrenal insufficiency † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Eye disorders    
Neuropathy: cranial - CN II Vision † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Ophthalmoplegia/diplopia (double vision) † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
vision blurred † 1  
# participants affected / at risk     3/12 (25.00%)  
# events     3  
Gastrointestinal disorders    
Colitis † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Constipation † 1  
# participants affected / at risk     2/12 (16.67%)  
# events     2  
Diarrhea † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Gastrointestinal-other - mouth sores † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Nausea † 1  
# participants affected / at risk     2/12 (16.67%)  
# events     2  
Pain - Abdomen NOS † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
vomiting † 1  
# participants affected / at risk     2/12 (16.67%)  
# events     2  
General disorders    
"Constitutional Symptoms - Other (Specify, cold † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Edema: limb † 1  
# participants affected / at risk     4/12 (33.33%)  
# events     6  
"Fatigue (asthenia, lethargy, malaise)" † 1  
# participants affected / at risk     9/12 (75.00%)  
# events     9  
"Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)" † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Rigors/chills † 1  
# participants affected / at risk     3/12 (25.00%)  
# events     3  
Immune system disorders    
Allergic reaction/hypersensitivity (including drug fever) † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Infections and infestations    
"Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)" † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
"Infection - Other (Specify, __)" - oral thrush † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
"Infection - Other (Specify, __)" - shingles † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis) † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
platelets † 1  
# participants affected / at risk     4/12 (33.33%)  
# events     8  
aspartate aminotransferase SGOT † 1  
# participants affected / at risk     3/12 (25.00%)  
# events     3  
Injury, poisoning and procedural complications    
Pain - Back † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Investigations    
Platelets † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Alkaline phosphatase † 1  
# participants affected / at risk     2/12 (16.67%)  
# events     2  
Creatinine † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
hemoglobin † 1  
# participants affected / at risk     6/12 (50.00%)  
# events     21  
alanine aminotransferase SGPT † 1  
# participants affected / at risk     3/12 (25.00%)  
# events     5  
total bilirubin † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Metabolism and nutrition disorders    
Anorexia † 1  
# participants affected / at risk     2/12 (16.67%)  
# events     2  
Dehydration † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
"Phosphate, serum-low (hypophosphatemia)" † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Hyponatremia † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Hyperglycemia † 1  
# participants affected / at risk     9/12 (75.00%)  
# events     13  
Hyperkalemia † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Hypocalcemia † 1  
# participants affected / at risk     2/12 (16.67%)  
# events     2  
Hypokalemia † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Hypomagnesemia † 1  
# participants affected / at risk     2/12 (16.67%)  
# events     2  
Hyponatremia † 1  
# participants affected / at risk     4/12 (33.33%)  
# events     9  
Musculoskeletal and connective tissue disorders    
"Muscle weakness, generalized or specific area (not due to neuropathy) - Left-sided" † 1  
# participants affected / at risk     4/12 (33.33%)  
# events     6  
Pain - Extremity-limb † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Pain - Miuscle † 1  
# participants affected / at risk     2/12 (16.67%)  
# events     2  
Nervous system disorders    
Ataxia (incoordination) † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Dizziness † 1  
# participants affected / at risk     2/12 (16.67%)  
# events     2  
Memory impairment † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Neuropathy: motor † 1  
# participants affected / at risk     2/12 (16.67%)  
# events     2  
Neuropathy: sensory † 1  
# participants affected / at risk     2/12 (16.67%)  
# events     3  
Pain - Head/headache † 1  
# participants affected / at risk     4/12 (33.33%)  
# events     4  
seizure † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
somnolence † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
speech impairment † 1  
# participants affected / at risk     2/12 (16.67%)  
# events     2  
tremor † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Psychiatric disorders    
Confusion † 1  
# participants affected / at risk     6/12 (50.00%)  
# events     7  
Mood alteration - Anxiety † 1  
# participants affected / at risk     3/12 (25.00%)  
# events     3  
Mood alteration - Depression † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Respiratory, thoracic and mediastinal disorders    
Cough † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Dyspnea (shortness of breath) † 1  
# participants affected / at risk     2/12 (16.67%)  
# events     2  
"Pulmonary/Upper Respiratory - Other (Specify, __)" † 1 [3]  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Skin and subcutaneous tissue disorders    
Dry skin † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Pruritus/itching † 1  
# participants affected / at risk     2/12 (16.67%)  
# events     2  
Rash/desquamation † 1  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Vascular disorders    
Hypotension † 1  
# participants affected / at risk     3/12 (25.00%)  
# events     3  
thrombosis † 1 [4]  
# participants affected / at risk     1/12 (8.33%)  
# events     1  
Events were collected by systematic assessment
1 Term from vocabulary, CTCAE (3.0)
[3] diminished breath sounds
[4] RLE DVT



  Limitations and Caveats
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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
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


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