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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02154 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2721 | |||
| 2721.00 | Other Identifier | Fred Hutch/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 pilot, phase I trial studies the safety of cancer-testis antigen (NY-ESO-1)-specific T cells (a type of immune cell) in treating patients with NY-ESO-1-expressing sarcomas that have spread to other places in the body and are receiving palliative (relief of symptoms and suffering caused by cancer) radiation therapy. Placing a modified gene for NY-ESO-1 into white blood cells may help the body build an immune response to kill tumor cells that express NY-ESO-1. Palliative radiation therapy may help patients with advanced sarcoma live more comfortably. Giving NY-ESO-1-specific T cells following palliative radiation therapy may be a better treatment for patients with sarcomas.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (radiation and NY-ESO-1-specific T cells) | Experimental | 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. |
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| 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 Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03 | CTCAE v4.03 | Up to 12 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1 | RECIST at 6 weeks after treatment (non-radiated tumors only) | At 6 weeks post-treatment |
| Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers |
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Inclusion Criteria:
INCLUSION CRITERIA FOR SCREENING:
INCLUSION CRITERIA FOR TREATMENT:
Exclusion Criteria:
EXCLUSION CRITERIA FOR SCREENING:
EXCLUSION CRITERIA FOR TREATMENT:
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| Name | Affiliation | Role |
|---|---|---|
| Seth Pollack | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 2-3 days after completion of radiation therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Palliative Radiation Therapy | Radiation | Undergo palliative radiation therapy |
|
Over 5% tet+ cells at 6 weeks? Patients may have detectable NY-ESO-1 specific T cells by MHC tetramers but if they are less than 5% this will be considered negative. |
| Up to 6 weeks post-treatment |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 2-3 days after completion of radiation therapy. Autologous NY-ESO-1-specific CD8-positive T Lymphocytes |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03 | CTCAE v4.03 | treated patients | Posted | Number | participants | Up to 12 weeks post-treatment |
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| Secondary | T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1 | RECIST at 6 weeks after treatment (non-radiated tumors only) | Posted | Count of Participants | Participants | At 6 weeks post-treatment |
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| Secondary | Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers | Over 5% tet+ cells at 6 weeks? Patients may have detectable NY-ESO-1 specific T cells by MHC tetramers but if they are less than 5% this will be considered negative. | Posted | Count of Participants | Participants | Up to 6 weeks post-treatment |
|
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6 months
CTCAE v4.03
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 2-3 days after completion of radiation therapy. | 0 | 2 | 0 | 2 | 1 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | CTCAE v4.03 | Systematic Assessment | grade 1 |
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| cough | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Systematic Assessment | 2 separate events in 1 patient, one grade 1 and one grade 2 |
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| shortness of breath | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Systematic Assessment | grade 2 |
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This trial was ended early as persistence was not at the level we had hoped and we had the opportunity to pursue a more promising strategy.
The data is limited by having only 2 patients.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seth Pollack | Fred Hutchinson Cancer Research Center | 206-667-6629 | spollack@fhcrc.org |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Grade 1 Cough (probably related) |
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| Title | Denominators | Categories | ||||||
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