Clinical trial NCT02319824: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sarcoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-12-18
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03
timeFrame: Up to 12 weeks post-treatment
Secondary outcomes:
measure: T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1
timeFrame: At 6 weeks post-treatment
measure: Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers
timeFrame: Up to 6 weeks post-treatment
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Seth Pollack
role: PRINCIPAL_INVESTIGATOR
References: