NY-ESO-1 Specific T Cells After Cyclophosphamide in Treating Patients With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
This phase I trial studies the side effects and best way to give NY-ESO-1 specific T cells after cyclophosphamide in treating patients with advanced synovial sarcoma or myxoid/round cell liposarcoma. Placing a gene that has been created in the laboratory into white blood cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving NY-ESO-1 specific T cells with cyclophosphamide may kill more tumor cells.
Adult Synovial Sarcoma
Recurrent Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Biological: NY-ESO-1-specific T cells
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study To Determine the Feasibility of Treating Synovial Sarcoma and Myxoid/ Round Cell Liposarcoma Using Autologous NY-ESO-1 Specific CD8+ T Cells With Cyclophosphamide Pre-Conditioning But Without the Use of IL-2|
- Incidence of grade III or greater toxicity graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: Yes ]The type and grade of toxicities noted during therapy will be summarized for each dose level. All adverse events noted by the investigator will be tabulated according to the affected body system. Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters.
- Persistence of tetramer positive T cells [ Time Frame: At 4 weeks ] [ Designated as safety issue: No ]The standard deviation and variance will be determined.
- Persistence of tetramer positive T cells [ Time Frame: At 10 weeks ] [ Designated as safety issue: No ]The standard deviation and variance will be determined.
|Study Start Date:||February 2014|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (cyclophosphamide, NY-ESO-1 specific CD8+ T cells)
Patients receive cyclophosphamide IV on days -3 and -2 and NY-ESO-1 specific CD8+ T cells IV over 60 minutes on day 0.
Other Names:Biological: NY-ESO-1-specific T cells
Given IVOther: laboratory biomarker analysis
I. To confirm the safety of cancer-testis antigen (NY-ESO-1) specific T cells in patients with advanced synovial sarcoma and myxoid/round cell liposarcoma following conditioning with high dose cyclophosphamide.
I. To confirm the persistence of NY-ESO-1 tetramer positive cells in the peripheral blood at 10 weeks after T cell infusion for synovial sarcoma and myxoid/round cell liposarcoma patients receiving NY-ESO-1 specific T cells following cyclophosphamide conditioning but not post-infusion interleukin (IL)-2.
Patients receive cyclophosphamide intravenously (IV) on days -3 and -2 and NY-ESO-1 specific cluster of differentiation (CD)8+ T cells IV over 60 minutes on day 0.
After completion of study treatment, patients are followed up for up to 12 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02059850
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Not yet recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Seth Pollack 206-667-6629|
|Principal Investigator: Seth Pollack|
|Principal Investigator:||Seth Pollack||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|