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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-02464 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2720.00 | Other Identifier | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| K23CA175167 | U.S. NIH Grant/Contract | View source | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (cyclophosphamide, NY-ESO-1 specific T cells) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous NY-ESO-1-specific CD8-positive T Lymphocytes | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence of tetramer positive T cells | The standard deviation and variance will be determined. | At 4 weeks |
| Persistence of tetramer positive T cells | The standard deviation and variance will be determined. |
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Inclusion Criteria:
INCLUSION CRITERIA FOR SCREENING:
CRITERIA FOR LEUKAPHERESIS:
INCLUSION CRITERIA FOR TREATMENT:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seth Pollack | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| Cyclophosphamide | Drug | Given IV |
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| At 10 weeks |
| ID | Term |
|---|---|
| D013584 | Sarcoma, Synovial |
| D018208 | Liposarcoma, Myxoid |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008080 | Liposarcoma |
| D018205 | Neoplasms, Adipose Tissue |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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