Description:
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.
Title
- Brief Title: NY-ESO-1-Specific T-cells in Treating Patients With Advanced NY-ESO-1-Expressing Sarcomas Receiving Palliative Radiation Therapy
- Official Title: A Pilot Trial of NY-ESO-1-Specific T Cells in Patients With Metastatic NY-ESO-1-Expressing Sarcomas Receiving Palliative Radiation
Clinical Trial IDs
- ORG STUDY ID:
2721.00
- SECONDARY ID:
NCI-2014-02154
- SECONDARY ID:
2721
- SECONDARY ID:
2721.00
- SECONDARY ID:
K23CA175167
- SECONDARY ID:
P30CA015704
- NCT ID:
NCT02319824
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Autologous NY-ESO-1-specific CD8-positive T Lymphocytes | | Treatment (radiation and NY-ESO-1-specific T cells) |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | - Autologous NY-ESO-1-specific CD8-positive T Lymphocytes
|
Eligibility Criteria
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
Exclusion Criteria:
EXCLUSION CRITERIA FOR SCREENING:
- Patients who do not meet the above inclusion criteria will not receive leukapheresis
EXCLUSION CRITERIA FOR TREATMENT:
- Patients with a history of proven myocarditis, pericarditis, or endocarditis
- Pregnant women, nursing women, men and women of reproductive ability who are unwilling
to use effective contraception or abstinence; women of childbearing potential must
have a negative pregnancy test within two weeks prior to study entry
- Inadequate renal function as indicated by serum creatinine >= 1.5 times the upper
limit of normal
- Inadequate liver function as indicated by total bilirubin >= 1.5 times the upper limit
of normal
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >= 2.5 times the
upper limit of normal
- Active symptomatic congestive heart failure
- Clinically significant hypotension
- Newly diagnosed cardiac arrhythmia; patients with an arrhythmia that has been stable
for at least 3 months will be allowed to participate
- Known untreated central nervous system (CNS) metastasis
- Patients with systemic infections requiring antibiotics or chronic
maintenance/suppressive therapy
- Patients receiving systemic anticancer therapy (chemotherapy, "biologics",
immunotherapy) less than 2 weeks prior to starting radiation
- Clinically significant autoimmune disorders requiring on-going systemic
immune-suppression for control
- Patients with acquired immunodeficiency syndrome (AIDS) or who are known to be human
immunodeficiency virus (HIV) positive are not eligible for this study; testing may
have been done up to 3 months prior to treatment
- Current treatment with steroids
- Known infection with hepatitis B virus (HBV) and hepatitis C virus (HCV); testing may
have been done up to 3 months prior to treatment
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03 |
Time Frame: | Up to 12 weeks post-treatment |
Safety Issue: | |
Description: | CTCAE v4.03 |
Secondary Outcome Measures
Measure: | T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1 |
Time Frame: | At 6 weeks post-treatment |
Safety Issue: | |
Description: | RECIST at 6 weeks after treatment (non-radiated tumors only) |
Measure: | Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers |
Time Frame: | Up to 6 weeks post-treatment |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Fred Hutchinson Cancer Research Center |
Last Updated
July 5, 2017