NY-ESO-1-Specific T-cells in Treating Patients With Advanced NY-ESO-1-Expressing Sarcomas Receiving Palliative Radiation Therapy
|Sarcoma||Biological: Autologous NY-ESO-1-specific CD8-positive T Lymphocytes Other: Laboratory Biomarker Analysis Radiation: Palliative Radiation Therapy||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Trial of NY-ESO-1-Specific T Cells in Patients With Metastatic NY-ESO-1-Expressing Sarcomas Receiving Palliative Radiation|
- 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.
|Study Start Date:||January 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
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
Given IVOther: Laboratory Biomarker Analysis
Correlative studiesRadiation: Palliative Radiation Therapy
Undergo palliative radiation therapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|