NY-ESO-1 Specific T Cells After Cyclophosphamide in Treating Patients With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
|ClinicalTrials.gov Identifier: NCT02059850|
Recruitment Status : Withdrawn
First Posted : February 11, 2014
Last Update Posted : February 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Adult Synovial Sarcoma Myxoid/Round Cell Liposarcoma Recurrent Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma||Biological: Autologous NY-ESO-1-specific CD8-positive T Lymphocytes Drug: Cyclophosphamide Other: Laboratory Biomarker Analysis||Phase 1|
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.
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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Treatment (cyclophosphamide, NY-ESO-1 specific T cells)
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
Other: Laboratory Biomarker Analysis
- 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 ]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 ]The standard deviation and variance will be determined.
- Persistence of tetramer positive T cells [ Time Frame: At 10 weeks ]The standard deviation and variance will be determined.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059850
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Seth Pollack||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|