A Phase 1 interventional study of Autologous NY-ESO-1-specific CD8-positive T Lymphocytes and Cyclophosphamide in Adult Synovial Sarcoma, Myxoid/Round Cell Liposarcoma and Recurrent Adult Soft Tissue Sarcoma, sponsored by Fred Hutchinson Cancer Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-02-03.
Sponsored by Fred Hutchinson Cancer Center · Phase 1, Interventional, and Treatment
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.
PRIMARY OBJECTIVES:
I. To confirm the safety and efficacy of cancer-testis antigen (NY-ESO-1) specific T cells (autologous NY-ESO-1-specific cluster of differentiation [CD]8-positive T lymphocytes) in patients with advanced synovial sarcoma and myxoid/round cell liposarcoma following conditioning with high dose cyclophosphamide.
SECONDARY OBJECTIVES:
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.
OUTLINE:
Patients receive cyclophosphamide intravenously (IV) on days -3 and -2 and NY-ESO-1 specific T cells IV over 60 minutes on day 0. Patients may receive additional infusions at the discretion of the Principal Investigator (PI).
After completion of study treatment, patients are followed up for up to 12 weeks.
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Inclusion Criteria:
INCLUSION CRITERIA FOR SCREENING:
CRITERIA FOR LEUKAPHERESIS:
INCLUSION CRITERIA FOR TREATMENT:
Exclusion Criteria:
Patients receive cyclophosphamide IV on days -3 and -2 and NY-ESO-1 specific T cells IV over 60 minutes on day 0. Patients may receive additional infusions at the discretion of the PI.
Biological: Autologous NY-ESO-1-specific CD8-positive T Lymphocytes · Drug: Cyclophosphamide · Other: Laboratory Biomarker Analysis
Given IV
Given IV
Correlative studies
Incidence of grade III or greater toxicity graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
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.
Time frame: Up to 10 weeks
Persistence of tetramer positive T cells
The standard deviation and variance will be determined.
Time frame: At 4 weeks
Persistence of tetramer positive T cells
The standard deviation and variance will be determined.
Time frame: At 10 weeks
This study is withdrawn, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Fred Hutchinson Cancer Center