NY-ESO-1-Specific T-cells in Treating Patients With Advanced NY-ESO-1-Expressing Sarcomas Receiving Palliative Radiation Therapy

Completed · Phase 1

Conditions studied: Sarcoma

In brief

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.

Key facts

Study ID

NCT02319824

Run by

Fred Hutchinson Cancer Center

People needed

2

Starts

2015-01-01

Last updated by the study team

2017-07-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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