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
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Biological: Autologous NY-ESO-1-specific CD8-positive T Lymphocytes Other: Laboratory Biomarker Analysis Radiation: Palliative Radiation Therapy||Phase 1|
I. To evaluate the safety and toxicity of NY-ESO-1-specific T cells when given following high-dose, hypo-fractionated palliative radiation to patients with advanced NY-ESO-1 expressing sarcomas.
I. To look for preliminary evidence of systemic efficacy of NY-ESO-1-specific T-cell therapy following radiation on non-radiated tumors.
II. To determine whether radiation increases trafficking of adoptively transferred NY-ESO-1-specific T cells by comparing tumor biopsy specimens from radiated and non-radiated tumors.
Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells intravenously (IV) over 60 minutes 2-3 days after completion of radiation therapy.
After completion of study treatment, patients are followed up weekly for 2 weeks, at 4-6, 8, 10, and 12 weeks, and then for up to 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Trial of NY-ESO-1-Specific T Cells in Patients With Metastatic NY-ESO-1-Expressing Sarcomas Receiving Palliative Radiation|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||June 2015|
Experimental: Treatment (radiation and NY-ESO-1-specific T cells)
Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells IV over 60 minutes 2-3 days after completion of radiation therapy.
Biological: Autologous NY-ESO-1-specific CD8-positive T Lymphocytes
Other: Laboratory Biomarker Analysis
Radiation: Palliative Radiation Therapy
Undergo palliative radiation therapy
- Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03 [ Time Frame: Up to 12 weeks post-treatment ]CTCAE v4.03
- T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1 [ Time Frame: At 6 weeks post-treatment ]RECIST at 6 weeks after treatment (non-radiated tumors only)
- Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers [ Time Frame: Up to 6 weeks post-treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319824
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Seth Pollack||Fred Hutch/University of Washington Cancer Consortium|