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: 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 ]The highest toxicity grades per patient will be tabulated for adverse events and laboratory measurements, and the number and percent of patients reporting adverse events (all, severe or worse, serious, and related) will be quantified.
- T cell transfer based on Response Evaluation Criteria In Solid Tumors v1.1 [ Time Frame: At 6 weeks post-treatment ]
- Transferred NY-ESO-1-specific T cells based on flow cytometry using major histocompatibility complex tetramers [ Time Frame: Up to 6 weeks post-treatment ]This is a composite outcome measure. Summary statistics used for describing changes across time. In addition, time course of biomarker outcomes investigated graphically, by summary plots or individual patient plots. Categorical data analyses and logistic regression used to evaluate the associations between correlative measures and clinical outcomes (e.g., response, clinical benefit, time to progression, progression-free survival, and survival). If there is suggestion of meaningful trend, methods such as linear mixed models may be used to characterize the pattern of change over time.
|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|