Sarcoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Given IV
OTHERLaboratory Biomarker Analysis
Correlative studies
RADIATIONPalliative Radiation Therapy
Undergo palliative radiation therapy
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
INCLUSION CRITERIA FOR SCREENING: * Histopathological documentation of sarcoma * Patients must express NY-ESO-1 in their tumor by immunohistochemistry (IHC) (\> 5%) prior to leukapheresis * For leukapheresis, patients must meet the following criteria (any exceptions to this will require prior approval by the apheresis director and principal investigator \[PI\]): * Pulse \> 45 or \< 120 * Weight \>= 45 kg * Temperature =\< 38° Celsius (C) (=\< 100.4° Fahrenheit \[F\]) * White blood cell count (WBC) \>= 2,000 * Hematocrit (HCT) \>= 30% * Platelets \>= 75,000 INCLUSION CRITERIA FOR TREATMENT: * A diagnosis of a metastatic or unresectable sarcoma * Patient must have a biopsy-accessible tumor to be radiated * Patient must have consulted with a radiation oncologist who is planning radiation; their radiation oncologist should have documented plans to administer a dose of at least 30 Gy in 5 or fewer fractions * Human leukocyte antigen (HLA) type A0201 or A2402 * Zubrod (Eastern Cooperative Oncology Group \[ECOG\]) performance status of '0-2' * All patients must have an electrocardiogram (ECG) within 2 weeks of starting conditioning * All patients must have an echo or multigated acquisition (MUGA) scan showing ejection fraction (EF) \> 50% and normal troponin and creatine kinase MB (CK MB) performed within 90 days of starting treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03 | Up to 12 weeks post-treatment | CTCAE v4.03 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1 | At 6 weeks post-treatment | RECIST at 6 weeks after treatment (non-radiated tumors only) |
| Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers | Up to 6 weeks post-treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Treatment (Radiation and NY-ESO-1-specific T Cells) |
|---|---|
| Age, Customized | 40 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03
CTCAE v4.03
Time frame: Up to 12 weeks post-treatment
Population: treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Radiation and NY-ESO-1-specific T Cells) | Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03 | Grade 1 Rash (likely related) | 1 participants |
| Treatment (Radiation and NY-ESO-1-specific T Cells) | Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03 | Grade 2 Shortness of breath (possibly related) | 1 participants |
| Treatment (Radiation and NY-ESO-1-specific T Cells) | Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03 | Grade 2 Cough (possibly related) | 1 participants |
| Treatment (Radiation and NY-ESO-1-specific T Cells) | Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03 | Grade 1 Cough (probably related) | 1 participants |
Secondary
T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1
RECIST at 6 weeks after treatment (non-radiated tumors only)
Time frame: At 6 weeks post-treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Radiation and NY-ESO-1-specific T Cells) | T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1 | SD | 1 Participants |
| Treatment (Radiation and NY-ESO-1-specific T Cells) | T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1 | PD | 1 Participants |
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.
Time frame: Up to 6 weeks post-treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Radiation and NY-ESO-1-specific T Cells) | Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers | Number of patients with <5% of CD8 T cells tet+ | 2 Participants |
| Treatment (Radiation and NY-ESO-1-specific T Cells) | Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers | >5% | 0 Participants |