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Trial record 47 of 283 for:    Tumor infiltrating lymphocytes

Evaluation of Apricoxib (Selective Cyclooxygenase 2 Inhibition) in Modulating T Regulatory Cells of Patients With Early Stage Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01532362
Recruitment Status : Terminated (Drug sponsor stopped drug manufacture due to toxicity issues from other studies)
First Posted : February 14, 2012
Results First Posted : February 11, 2016
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Non Small Cell Lung Cancer
Intervention Drug: Apricoxib
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Apricoxib No Drug Intervention
Hide Arm/Group Description As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries. no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
Period Title: Overall Study
Started 1 0
Completed 1 0
Not Completed 0 0
Arm/Group Title Apricoxib No Drug Intervention Total
Hide Arm/Group Description As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries. no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries. Total of all reporting groups
Overall Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
>=65 years
1
 100.0%
1
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female
1
 100.0%
1
 100.0%
Male
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
White
1
 100.0%
1
 100.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 0 participants 1 participants
1 1
1.Primary Outcome
Title Compare Level of CD4+CD25high T Lymphocyte Regulatory Cells in Peripheral Blood Lymphocytes and Tumor Infiltrating Lymphocytes From Surgical Resection Specimens of Subjects With Early Stage NSCLC Who Have Received Apricoxib to Those Who Have Not
Hide Description As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries. Peripheral blood and urine will be obtained on Days 0 and 7 from both groups (prior to surgical incision). Bronchoalveolar lavage (BAL) and lymph node tissue will be obtained on Days 0 and 7. TIL will be obtained from surgical resection specimens of the primary lung tumor only on Day 7
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis occurred
Arm/Group Title Apricoxib No Drug Intervention
Hide Arm/Group Description:
As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Effect of Apricoxib on Levels of CD4+CD25+ T Regulatory Cells in Peripheral Blood.Also,Biomarkers of Apoptosis Resistance,Angiogenesis,Invasion and Immunity Will be Tested in the Lab to Check How Effective Apricoxib is in Inhibiting These Proteins.
Hide Description Peripheral blood from patients with NSCLC has been reported to have an increase in the percentages of CD4+CD25+ T reg cells.In contrast <10% of the PBLs of normal donors have this phenotype. As such, CD4+CD25+ cells will be assessed in addition to FOXP3 levels in PBL. In addition, exploration of COX-2 dependent biomarkers of apoptosis resistance, angiogenesis, invasion, and immunity will be studied. COX-2, FOXP3, IL-10, IL-12, MDC, CXCR4 and survivin will be analyzed in plasma.
Time Frame 7 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Apricoxib No Drug Intervention
Hide Arm/Group Description As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries. no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
All-Cause Mortality
Apricoxib No Drug Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Apricoxib No Drug Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Apricoxib No Drug Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Early termination of study when sponsor withdrew drug from market due to toxicities revealed from other studies.
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. Jay Moon Lee
Organization: Jonsson Comprehensive Cancer Center: University of California at Los Angeles
Phone: (310) 794-7333
Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01532362     History of Changes
Other Study ID Numbers: 11-002081
First Submitted: November 30, 2011
First Posted: February 14, 2012
Results First Submitted: January 12, 2016
Results First Posted: February 11, 2016
Last Update Posted: December 11, 2017