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

NCT02319824

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.

Related Conditions:
  • Sarcoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

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

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

    NCT ID: NCT02319824

    ORG ID: 2721.00

    NCI ID: NCI-2014-02154

    Trial Conditions

    Sarcoma

    Trial Interventions

    Drug Synonyms Arms

    Trial 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.

    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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Incidence of adverse events measured by the National Cancer Institute Common Terminology Criteria for Adverse Events version (v)4.03

    Secondary Outcome Measures

    T cell transfer based on Response Evaluation Criteria In Solid Tumors v1.1

    Transferred NY-ESO-1-specific T cells based on flow cytometry using major histocompatibility complex tetramers

    Trial Keywords