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Trial record 42 of 156 for:    "Primary Central Nervous System Lymphoma"

Combined Immunochemotherapy Followed By Reduced Dose Radiation Therapy (RT) for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

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ClinicalTrials.gov Identifier: NCT00594815
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Collaborators:
Northwestern Memorial Hospital
Columbia University
Kentuckiana Cancer Institute
University of Virginia
University of Vermont
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Intervention Drug: Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine
Enrollment 52
Recruitment Details Protocol Open to Accrual 08/08/2002 Protocol Closed to Accrual 03/10/2009 Primary Completion Date 02-23-2016 Recruitment Location is the medical clinic
Pre-assignment Details  
Arm/Group Title Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
Hide Arm/Group Description Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
Period Title: Overall Study
Started 52
Completed 43
Not Completed 9
Reason Not Completed
Never Treated             3
Withdrawal by Subject             2
Toxicity             4
Arm/Group Title Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
Hide Arm/Group Description Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
Overall Number of Baseline Participants 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
<=18 years
0
   0.0%
Between 18 and 65 years
34
  65.4%
>=65 years
18
  34.6%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 52 participants
60
(30 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Female
22
  42.3%
Male
30
  57.7%
1.Primary Outcome
Title Total Number of Participants Who Experienced Acute Treatment Related Adverse Events
Hide Description The toxicity of this combined regimen will be measured using the NCI CTC version 2.0.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
Hide Arm/Group Description:
Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
Overall Number of Participants Analyzed 52
Measure Type: Count of Participants
Unit of Measure: Participants
52
 100.0%
2.Primary Outcome
Title Progression Free Survival
Hide Description Overall Progression Free Survival at 2 years
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
Hide Arm/Group Description:
Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
Overall Number of Participants Analyzed 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
57
(44 to 71)
Time Frame Every other week during treatment cycles. Follow up evaluation will be assessed every 3 months for the first year after completing treatment. Follow up will then be done every 4 months for the second year, every 6 months until the 5th year and then annually.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
Hide Arm/Group Description This is a single-armed pilot study designed to evaluate the safety and efficacy of combined immunochemotherapy followed by reduced dose radiation for participants with newly diagnosed PCNSL.
All-Cause Mortality
Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
Affected / at Risk (%)
Total   13/52 (25.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
Affected / at Risk (%)
Total   22/52 (42.31%) 
Blood and lymphatic system disorders   
Leukocytes  1  4/52 (7.69%) 
Cardiac disorders   
Hypotension  1  2/52 (3.85%) 
Eye disorders   
Vision-double vision  1  1/52 (1.92%) 
Gastrointestinal disorders   
Dehydration  1  1/52 (1.92%) 
Duodenal ulcer  1  1/52 (1.92%) 
Radiation mucositis  1  1/52 (1.92%) 
Nausea  1  1/52 (1.92%) 
Vomiting  1  1/52 (1.92%) 
General disorders   
Fever  1  2/52 (3.85%) 
Pain, other  1  1/52 (1.92%) 
Infections and infestations   
Febrile neutropenia  1  3/52 (5.77%) 
Infection without neutropenia  1  4/52 (7.69%) 
Infection  1  1/52 (1.92%) 
Wound, infectious  1  3/52 (5.77%) 
Investigations   
Neutrophils/granulocytes  1  4/52 (7.69%) 
Platelets  1  4/52 (7.69%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/52 (1.92%) 
Nervous system disorders   
Ataxia  1  1/52 (1.92%) 
Neurology, other  1  2/52 (3.85%) 
Psychiatric disorders   
Hallucinations  1  1/52 (1.92%) 
Mood alteration-anxiety  1  1/52 (1.92%) 
Mood alteration - depression  1  1/52 (1.92%) 
Personality/behavior  1  1/52 (1.92%) 
Renal and urinary disorders   
Elevated Creatinine  1  1/52 (1.92%) 
Renal failure  1  1/52 (1.92%) 
Renal/GU, other  1  1/52 (1.92%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/52 (1.92%) 
Pulmonary, other  1  1/52 (1.92%) 
Vascular disorders   
Thrombosis  1  1/52 (1.92%) 
1
Term from vocabulary, CTCAE (2.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
Affected / at Risk (%)
Total   43/52 (82.69%) 
Blood and lymphatic system disorders   
Hemoglobin/Anemia  1  33/52 (63.46%) 
Gastrointestinal disorders   
Constipation  1  5/52 (9.62%) 
General disorders   
Fatigue  1  4/52 (7.69%) 
Hepatobiliary disorders   
Bilirubin  1  5/52 (9.62%) 
Immune system disorders   
Leukocytes  1  31/52 (59.62%) 
Lymphopenia  1  30/52 (57.69%) 
Investigations   
SGPT (ALT)  1  24/52 (46.15%) 
Neutrophils/granulocytes  1  22/52 (42.31%) 
SGOT (AST)  1  16/52 (30.77%) 
Platelets  1  14/52 (26.92%) 
PT  1  9/52 (17.31%) 
PTT  1  6/52 (11.54%) 
Metabolism and nutrition disorders   
Hypocalcemia  1  36/52 (69.23%) 
Hyperglycemia  1  36/52 (69.23%) 
Hypophosphatemia  1  10/52 (19.23%) 
Hypoalbuminemia  1  8/52 (15.38%) 
Hyponatremia  1  7/52 (13.46%) 
Hypokalemia  1  7/52 (13.46%) 
Hypoglycemia  1  4/52 (7.69%) 
Hyperkalemia  1  3/52 (5.77%) 
Nervous system disorders   
Neuropathy-sensory  1  3/52 (5.77%) 
Renal and urinary disorders   
Creatinine  1  6/52 (11.54%) 
1
Term from vocabulary, CTCAE (2.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Antonio Omuro
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-7523
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00594815     History of Changes
Obsolete Identifiers: NCT00059956
Other Study ID Numbers: 01-146
First Submitted: January 7, 2008
First Posted: January 16, 2008
Results First Submitted: February 13, 2017
Results First Posted: April 6, 2017
Last Update Posted: April 6, 2017