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Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen

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ClinicalTrials.gov Identifier: NCT00074165
Recruitment Status : Terminated (Lack of accrual)
First Posted : December 11, 2003
Results First Posted : November 16, 2011
Last Update Posted : April 21, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Edward Neuwelt, OHSU Knight Cancer Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Brain and Central Nervous System Tumors
Drug/Agent Toxicity by Tissue/Organ
Lymphoma
Thrombocytopenia
Interventions Drug: Rituxan
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Etoposide phosphate
Drug: Carboplatin
Drug: Sodium thiosulfate
Drug: Neupogen
Drug: Neulasta
Drug: Cytarabine
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab and Carboplatin
Hide Arm/Group Description Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
Period Title: Overall Study
Started 17
Completed 17
Not Completed 0
Arm/Group Title Rituximab and Carboplatin
Hide Arm/Group Description Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
  70.6%
>=65 years
5
  29.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
55.235  (12.799)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
8
  47.1%
Male
9
  52.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
1.Primary Outcome
Title Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years.
Hide Description Per RECIST criteria (v1.1) and assessed by magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab and Carboplatin
Hide Arm/Group Description:
Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: Participants
1
2.Secondary Outcome
Title Number of Participants With Overall Survival Assessed by Clinical and Radiographic Response
Hide Description Overall survival is measured from entry onto study until death from any cause or until death or progression of disease, respectively.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Inadequate sample size to determine overall survival
Arm/Group Title Rituximab and Carboplatin
Hide Arm/Group Description:
Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Progression-free Survival Assessed by Clinical and Radiographic Response From First Day of Treatment Until Tumor Progression
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Quality of Life Assessed by EORTC QOL Before Treatment and Then Every 3 Months
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Ototoxicity Assessed by Audiology Hearing Test Done Monthly During Treatment
Hide Description [Not Specified]
Time Frame 2 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Effect of Sodium Thiosulfate (STS) on Granulocytes and Erythrocytes Assessed by Complete Blood Count Lab Values Done Weekly During Treatment
Hide Description [Not Specified]
Time Frame 2 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab and Carboplatin
Hide Arm/Group Description Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
All-Cause Mortality
Rituximab and Carboplatin
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Rituximab and Carboplatin
Affected / at Risk (%)
Total   16/17 (94.12%) 
Blood and lymphatic system disorders   
Neutropenic Fever  2/17 (11.76%) 
Anemia  1/17 (5.88%) 
Carotid Artery Tear  1/17 (5.88%) 
Electrolyte Imbalance and Increased Blood Sodium  1/17 (5.88%) 
Cardiac disorders   
Atrial Fibrillation  1/17 (5.88%) 
General disorders   
Unresponsiveness [1]  1/17 (5.88%) 
Death  1/17 (5.88%) 
Injury, poisoning and procedural complications   
Hospitalized for Fall  1/17 (5.88%) 
Investigations   
Extended Hospitalization  2/17 (11.76%) 
Musculoskeletal and connective tissue disorders   
Superficial Epidermolysis  1/17 (5.88%) 
Psychiatric disorders   
Neurological Symptoms  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Bronchitis  1/17 (5.88%) 
Vascular disorders   
Stroke  1/17 (5.88%) 
Chemical Meningitis and Seizures  1/17 (5.88%) 
[1]
Hospitalized for unresponsiveness
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rituximab and Carboplatin
Affected / at Risk (%)
Total   1/17 (5.88%) 
General disorders   
Leg Pain  1/17 (5.88%) 
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: Dr. Edward Neuwelt
Organization: OHSU Knight Cancer Institute
Phone: 503-494-5626
EMail: neuwelte@ohsu.edu
Layout table for additonal information
Responsible Party: Edward Neuwelt, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00074165    
Obsolete Identifiers: NCT00261651
Other Study ID Numbers: IRB00000641
5R01CA137488-15 ( U.S. NIH Grant/Contract )
ONC-02059-LX ( Other Identifier: OHSU Knight Cancer Institute )
641 ( Other Identifier: OHSU eIRB )
7465 ( Other Identifier: OHSU IRB (discontinued number) )
OHSU-641 ( Other Identifier: OHSU IRB )
First Submitted: December 10, 2003
First Posted: December 11, 2003
Results First Submitted: October 10, 2011
Results First Posted: November 16, 2011
Last Update Posted: April 21, 2017