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NY-ESO-1-Specific T-cells in Treating Patients With Advanced NY-ESO-1-Expressing Sarcomas Receiving Palliative Radiation Therapy

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ClinicalTrials.gov Identifier: NCT02319824
Recruitment Status : Completed
First Posted : December 18, 2014
Results First Posted : July 5, 2017
Last Update Posted : July 5, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Seth Pollack, Fred Hutchinson Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sarcoma
Interventions Biological: Autologous NY-ESO-1-specific CD8-positive T Lymphocytes
Other: Laboratory Biomarker Analysis
Radiation: Palliative Radiation Therapy
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Radiation and NY-ESO-1-specific T Cells)
Hide Arm/Group Description Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells IV 2-3 days after completion of radiation therapy.
Period Title: Overall Study
Number of participants Number of units (NY-ESO-1 specific T cells)
Started 2 2
Completed 2 2
Not Completed 0 0
Arm/Group Title Treatment (Radiation and NY-ESO-1-specific T Cells)
Hide Arm/Group Description

Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy.

Autologous NY-ESO-1-specific CD8-positive T Lymphocytes
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants
40
(27 to 53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
2
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03
Hide Description CTCAE v4.03
Time Frame Up to 12 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
treated patients
Arm/Group Title Treatment (Radiation and NY-ESO-1-specific T Cells)
Hide Arm/Group Description:
Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells I60 minutes 2-3 days after completion of radiation therapy.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
Grade 1 Rash (likely related) 1
Grade 2 Shortness of breath (possibly related) 1
Grade 2 Cough (possibly related) 1
Grade 1 Cough (probably related) 1
2.Secondary Outcome
Title T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1
Hide Description RECIST at 6 weeks after treatment (non-radiated tumors only)
Time Frame At 6 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Radiation and NY-ESO-1-specific T Cells)
Hide Arm/Group Description:
Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy.
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
SD
1
  50.0%
PD
1
  50.0%
3.Secondary Outcome
Title Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers
Hide Description Over 5% tet+ cells at 6 weeks? Patients may have detectable NY-ESO-1 specific T cells by MHC tetramers but if they are less than 5% this will be considered negative.
Time Frame Up to 6 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Radiation and NY-ESO-1-specific T Cells)
Hide Arm/Group Description:
Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy.
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients with <5% of CD8 T cells tet+
2
 100.0%
>5%
0
   0.0%
Time Frame 6 months
Adverse Event Reporting Description CTCAE v4.03
 
Arm/Group Title Treatment (Radiation and NY-ESO-1-specific T Cells)
Hide Arm/Group Description Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells 2-3 days after completion of radiation therapy.
All-Cause Mortality
Treatment (Radiation and NY-ESO-1-specific T Cells)
Affected / at Risk (%)
Total   0/2 (0.00%)    
Hide Serious Adverse Events
Treatment (Radiation and NY-ESO-1-specific T Cells)
Affected / at Risk (%) # Events
Total   0/2 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Radiation and NY-ESO-1-specific T Cells)
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Respiratory, thoracic and mediastinal disorders   
cough † 1 [1]  1/2 (50.00%)  2
shortness of breath † 1 [2]  1/2 (50.00%)  1
Skin and subcutaneous tissue disorders   
Rash † 1 [3]  1/2 (50.00%)  1
1
Term from vocabulary, CTCAE v4.03
†
Indicates events were collected by systematic assessment
[1]
2 separate events in 1 patient, one grade 1 and one grade 2
[2]
grade 2
[3]
grade 1

This trial was ended early as persistence was not at the level we had hoped and we had the opportunity to pursue a more promising strategy.

The data is limited by having only 2 patients.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Seth Pollack
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-667-6629
EMail: spollack@fhcrc.org
Layout table for additonal information
Responsible Party: Seth Pollack, Fred Hutchinson Cancer Center
ClinicalTrials.gov Identifier: NCT02319824    
Other Study ID Numbers: 2721.00
NCI-2014-02154 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2721
2721.00 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
K23CA175167 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: November 5, 2014
First Posted: December 18, 2014
Results First Submitted: April 18, 2017
Results First Posted: July 5, 2017
Last Update Posted: July 5, 2017