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Trial record 12 of 15 for:    "Central Nervous System Lymphoma" | "Dexamethasone"

Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma

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ClinicalTrials.gov Identifier: NCT00335140
Recruitment Status : Terminated (slow accrual)
First Posted : June 8, 2006
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Interventions Biological: Rituximab
Drug: Cytarabine
Drug: Dexamethasone
Drug: Leucovorin
Drug: Methotrexate
Drug: Procarbazine
Drug: Vincristine
Enrollment 26
Recruitment Details Participants were recruited from ECOG-ACRIN member institutions starting 12/21/2006. The study was suspended 2/24/2010 for interim analysis. After the interim analysis, it was determined that the goals of the study had been met and the study was closed on 4/12/2013.
Pre-assignment Details  
Arm/Group Title Rituximab + Standard Chemotherapy
Hide Arm/Group Description

rituximab

cytarabine

dexamethasone

leucovorin calcium

methotrexate

procarbazine hydrochloride

vincristine sulfate

Period Title: Overall Study
Started 26
Eligible 25
Treated 25
Completed 25
Not Completed 1
Reason Not Completed
Ineligible             1
Arm/Group Title Rituximab + Standard Chemotherapy
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rituximab

cytarabine

dexamethasone

leucovorin calcium

methotrexate

procarbazine hydrochloride

vincristine sulfate

Overall Number of Baseline Participants 25
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Eligible patients who began protocol therapy
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Age Number Analyzed 25 participants
Age < 60 years
15
  60.0%
Age ≥ 60 years
10
  40.0%
[1]
Measure Description: Older or younger than 60
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
15
  60.0%
Male
10
  40.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 25 participants
White
24
  96.0%
Asian
1
   4.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
ECOG Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
0
1
   4.0%
1
15
  60.0%
2
5
  20.0%
3
4
  16.0%
[1]
Measure Description:

0 = Fully active, able to carry on all pre-disease performance without restriction

  1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
  2. = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
  3. = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
  4. = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
Neurologic Function Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
No symptoms
0
   0.0%
Minor symptoms
11
  44.0%
Moderate symptoms/fully active
5
  20.0%
Moderate symptoms/less than fully active
7
  28.0%
Severe neurologic symptoms
2
   8.0%
Cerebrovascular Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Never
21
  84.0%
Symptomatic or on medication
4
  16.0%
Other Medical Problems at Baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Never
9
  36.0%
Symptomatic or on medication
7
  28.0%
Past history of
7
  28.0%
Missing/unknown
2
   8.0%
1.Primary Outcome
Title Complete Response Rate - Locally Reviewed
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Assessed by the ECOG-ACRIN data manager based upon local review of images and data sent by the local sites.

Treatment response was determined by calculating the sum of the maximal cross section in 2 separate axes using enhancing lesion(s) on CT or MRI imaging. The same imaging modality was to be used throughout assessment. Complete response was defined as the disappearance of all contrast enhancing tumor size on CT or MRI, patient was off all glucocorticoids, and resolution of all meningeal and vitreous involvement if present. Response must have lasted at least 4 weeks.

Time Frame For the primary endpoint, complete response will be based on disease status at three weeks post the end of therapy (week 17).
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Hide Analysis Population Description
Eligible, treated patients
Arm/Group Title Rituximab + Standard Chemotherapy
Hide Arm/Group Description:

rituximab

cytarabine

dexamethasone

leucovorin calcium

methotrexate

procarbazine hydrochloride

vincristine sulfate

Overall Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
64
(42.5 to 82)
Time Frame Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab + Standard Chemotherapy
Hide Arm/Group Description Rituximab + high dose methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine. Patients with meningeal involvement will receive additional methotrexate and leucovorin.
All-Cause Mortality
Rituximab + Standard Chemotherapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab + Standard Chemotherapy
Affected / at Risk (%)
Total   24/26 (92.31%) 
Blood and lymphatic system disorders   
Anemia  1  6/26 (23.08%) 
Febrile neutropenia  1  1/26 (3.85%) 
Gastrointestinal disorders   
Dysphagia  1  1/26 (3.85%) 
Muco/stomatitis by exam, oral cavity  1  1/26 (3.85%) 
Muco/stomatitis (symptom) esophagus  1  1/26 (3.85%) 
Muco/stomatitis (symptom) oral cavity  1  1/26 (3.85%) 
Perforation, colon  1  1/26 (3.85%) 
Perforation, stomach  1  1/26 (3.85%) 
Esophagus, pain  1  1/26 (3.85%) 
Oral cavity, pain  1  1/26 (3.85%) 
General disorders   
Fatigue  1  4/26 (15.38%) 
Infections and infestations   
Infection Gr0-2 neut, upper aerodig  1  1/26 (3.85%) 
Injury, poisoning and procedural complications   
Vascular access,Thrombosis/embolism  1  1/26 (3.85%) 
Investigations   
Leukocytes decreased  1  17/26 (65.38%) 
Lymphopenia  1  10/26 (38.46%) 
Neutrophils decreased  1  20/26 (76.92%) 
Platelets decreased  1  5/26 (19.23%) 
Alanine aminotransferase increased  1  7/26 (26.92%) 
Aspartate aminotransferase increased  1  4/26 (15.38%) 
Metabolism and nutrition disorders   
Hypocalcemia  1  1/26 (3.85%) 
Hyperglycemia  1  2/26 (7.69%) 
Hypophosphatemia  1  2/26 (7.69%) 
Hypokalemia  1  8/26 (30.77%) 
Hyponatremia  1  2/26 (7.69%) 
Musculoskeletal and connective tissue disorders   
Nonneuropathic lower extr muscle weak  1  1/26 (3.85%) 
Nonneuropathic generalized weakness  1  1/26 (3.85%) 
Extremity-limb, pain  1  1/26 (3.85%) 
Joint, pain  1  1/26 (3.85%) 
Muscle, pain  1  1/26 (3.85%) 
Nervous system disorders   
Ataxia  1  1/26 (3.85%) 
Neuropathy CN VI lateral deviation eye  1  1/26 (3.85%) 
Neuropathy-motor  1  3/26 (11.54%) 
Neuropathy-sensory  1  3/26 (11.54%) 
Head/headache  1  1/26 (3.85%) 
Psychiatric disorders   
Confusion  1  1/26 (3.85%) 
Depression  1  1/26 (3.85%) 
Respiratory, thoracic and mediastinal disorders   
Muco/stomatitis by exam, pharynx  1  1/26 (3.85%) 
Muco/stomatitis (symptom) pharynx  1  1/26 (3.85%) 
Throat/pharynx/larynx, pain  1  1/26 (3.85%) 
Hypoxia  1  1/26 (3.85%) 
Skin and subcutaneous tissue disorders   
Rash/desquamation  1  1/26 (3.85%) 
Vascular disorders   
Thrombosis/thrombus/embolism  1  3/26 (11.54%) 
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 + Standard Chemotherapy
Affected / at Risk (%)
Total   26/26 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  23/26 (88.46%) 
Eye disorders   
Vision-blurred  1  3/26 (11.54%) 
Tearing  1  2/26 (7.69%) 
Gastrointestinal disorders   
Constipation  1  9/26 (34.62%) 
Diarrhea w/o prior colostomy  1  8/26 (30.77%) 
Dry mouth  1  3/26 (11.54%) 
Dysphagia  1  2/26 (7.69%) 
Dyspepsia  1  3/26 (11.54%) 
Muco/stomatitis by exam, oral cavity  1  3/26 (11.54%) 
Muco/stomatitis (symptom) oral cavity  1  5/26 (19.23%) 
Nausea  1  13/26 (50.00%) 
Vomiting  1  7/26 (26.92%) 
Abdomen, pain  1  2/26 (7.69%) 
Oral cavity, pain  1  2/26 (7.69%) 
General disorders   
Fatigue  1  21/26 (80.77%) 
Rigors/chills  1  4/26 (15.38%) 
Edema limb  1  5/26 (19.23%) 
Extremity-lower (gait/walking)  1  2/26 (7.69%) 
Injury, poisoning and procedural complications   
Wound - non-infectious  1  2/26 (7.69%) 
Investigations   
Leukocytes decreased  1  24/26 (92.31%) 
Lymphopenia  1  12/26 (46.15%) 
Neutrophils decreased  1  11/26 (42.31%) 
Platelets decreased  1  19/26 (73.08%) 
Weight gain  1  3/26 (11.54%) 
Alkaline phosphatase increased  1  5/26 (19.23%) 
Alanine aminotransferase increased  1  15/26 (57.69%) 
Aspartate aminotransferase increased  1  11/26 (42.31%) 
Blood bilirubin increased  1  6/26 (23.08%) 
Creatinine increased  1  13/26 (50.00%) 
Metabolic/Laboratory-other  1  2/26 (7.69%) 
Metabolism and nutrition disorders   
Anorexia  1  6/26 (23.08%) 
Hypoalbuminemia  1  14/26 (53.85%) 
Acidosis  1  2/26 (7.69%) 
Hypercalcemia  1  2/26 (7.69%) 
Hypocalcemia  1  15/26 (57.69%) 
Hyperglycemia  1  12/26 (46.15%) 
Hypermagnesemia  1  3/26 (11.54%) 
Hypomagnesemia  1  4/26 (15.38%) 
Hypophosphatemia  1  3/26 (11.54%) 
Hyperkalemia  1  2/26 (7.69%) 
Hypokalemia  1  16/26 (61.54%) 
Hyponatremia  1  13/26 (50.00%) 
Musculoskeletal and connective tissue disorders   
Arthritis  1  2/26 (7.69%) 
Nonneuropathic generalized weakness  1  2/26 (7.69%) 
Extremity-limb, pain  1  2/26 (7.69%) 
Muscle, pain  1  6/26 (23.08%) 
Nervous system disorders   
Taste disturbance  1  4/26 (15.38%) 
Dizziness  1  4/26 (15.38%) 
Neuropathy-motor  1  5/26 (19.23%) 
Neuropathy-sensory  1  10/26 (38.46%) 
Speech impairment  1  2/26 (7.69%) 
Tremor  1  2/26 (7.69%) 
Head/headache  1  7/26 (26.92%) 
Psychiatric disorders   
Insomnia  1  6/26 (23.08%) 
Anxiety  1  6/26 (23.08%) 
Depression  1  4/26 (15.38%) 
Personality  1  2/26 (7.69%) 
Renal and urinary disorders   
Urinary frequency/urgency  1  4/26 (15.38%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  5/26 (19.23%) 
Cough  1  2/26 (7.69%) 
Dyspnea  1  7/26 (26.92%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  5/26 (19.23%) 
Rash/desquamation  1  4/26 (15.38%) 
Petechiae  1  2/26 (7.69%) 
Vascular disorders   
Hypertension  1  2/26 (7.69%) 
Hypotension  1  5/26 (19.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
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: Lode Swinnen, MD
Organization: Johns Hopkins Cancer Center
Phone: (410) 955-8603
Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00335140     History of Changes
Other Study ID Numbers: CDR0000475776
ECOG-E1F05 ( Other Identifier: ECOG-ACRIN )
First Submitted: June 7, 2006
First Posted: June 8, 2006
Results First Submitted: April 17, 2017
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017