NY-ESO-1-Specific T-cells in Treating Patients With Advanced NY-ESO-1-Expressing Sarcomas Receiving Palliative Radiation Therapy
Condition: Sarcoma
MeSH terms: Sarcoma
Intervention: Autologous NY-ESO-1-specific CD8-positive T Lymphocytes; Laboratory Biomarker Analysis; Palliative Radiation Therapy
Intervention description: Given IV; Correlative studies; Undergo palliative radiation therapy
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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