<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03017131</url>
  </required_header>
  <id_info>
    <org_study_id>i 283616</org_study_id>
    <secondary_id>NCI-2016-01477</secondary_id>
    <secondary_id>i 283616</secondary_id>
    <secondary_id>P30CA016056</secondary_id>
    <secondary_id>P50CA159981</secondary_id>
    <nct_id>NCT03017131</nct_id>
  </id_info>
  <brief_title>Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer</brief_title>
  <official_title>A Phase I Open Label Clinical Trial Evaluating the Safety and Efficacy of Adoptive Transfer of NY-ESO-1 TCR Engineered Autologous T Cells in Combination With Decitabine in Patients With Recurrent or Treatment Refractory Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Roswell Park Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I trial studies the side effects of genetically modified T cells and decitabine in&#xD;
      treating patients with recurrent or refractory epithelial or non-epithelial ovarian, primary&#xD;
      peritoneal, or fallopian tube cancer that has come back or has not responded to previous&#xD;
      treatments. White blood cells called T cells are collected via a process called&#xD;
      leukapheresis, genetically modified to recognize and attack tumor cells, then given back to&#xD;
      the patient. Decitabine may induce and increase the amount of the target protein NY-ESO-1&#xD;
      available on the surface of tumor cells. Giving genetically modified T cells and decitabine&#xD;
      may kill more tumor cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the safety and tolerability of the autologous NY-ESO-1 redirected T cell&#xD;
      therapy in combination with decitabine and low-dose IL-2 in patients with treatment&#xD;
      refractory or recurrent epithelial or non-epithelial ovarian, primary peritoneal or fallopian&#xD;
      tube carcinoma.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the persistence of genetically modified cells in the peripheral blood, and at&#xD;
      tumor sites.&#xD;
&#xD;
      II. To examine the effect of the treatment on tumor as measured by objective tumor response&#xD;
      and progression free survival, both assessed by immune-related Response Evaluation Criteria&#xD;
      in Solid Tumors (irRECIST).&#xD;
&#xD;
      III. To assess the occurrence of target antigen and/or major histocompatibality complex (MHC)&#xD;
      loss variants upon disease recurrence.&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the post treatment phenotype and functionality of genetically modified T cells&#xD;
      isolated from peripheral blood and from tumor sites.&#xD;
&#xD;
      II. To assess changes in immunoscore, Tregs, Myeloid cell subsets, and antigen spreading in&#xD;
      peripheral blood and tumor site.&#xD;
&#xD;
      III. To assess the influence of demographic and disease molecular characteristics on&#xD;
      treatment outcomes of complete response (CR) and overall survival (OS).&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      COURSE 1: Patients receive decitabine IV daily over 1 hour on days -8 to Day -6,&#xD;
      cyclophosphamide IV over 2 hours on days -4 and -3, and genetically engineered&#xD;
      NY-ESO-1-specific T lymphocytes IV and intraperitoneally (IP) on day 0. Followed by low-dose&#xD;
      IL-2 for 2 weeks from Day 1 to Day 14..&#xD;
&#xD;
      After completion of study treatment, patients are followed up monthly at 3-9 months, every 6&#xD;
      months for 4 years, and then annually for up to 15 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 8, 2017</start_date>
  <completion_date type="Anticipated">March 23, 2032</completion_date>
  <primary_completion_date type="Actual">March 23, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events version 4</measure>
    <time_frame>Up to 28 days post infusion</time_frame>
    <description>The frequency of toxicities will be tabulated by grade across all dose levels and cycles.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Appearance of target antigen/major histocompatibility complex loss variants upon disease recurrence</measure>
    <time_frame>Up to 15 years</time_frame>
    <description>Will be evaluated by quantifying expression of targeted antigens/major histocompatibility complex alleles (NY-ESO-1/human leukocyte antigen-A*02) in tumor samples obtained on disease recurrence if available, and comparing those values to the pretreatment (diagnosis) samples. NY-ESO-1 expression will be evaluated by quantitative real time polymerase chain reaction immunohistochemistry. Human leukocyte antigen-A*0201 expression on samples will be evaluated by immunohistochemistry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical response rates</measure>
    <time_frame>Up to 15 years</time_frame>
    <description>Percentage of complete and partial responses and the corresponding 95% confidence interval will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>Up to 15 years</time_frame>
    <description>Will be observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunological parameters associated with T cell persistence, bioactivity and functionality</measure>
    <time_frame>Up to 15 years</time_frame>
    <description>Will measure the pre- and post-treatment percentage of transgenic T cells in the peripheral blood, selective migration into the tumor sites, the ex-vivo immune functionality and phenotype of these cells, the modulation of cytokine milieu in serum post treatment as compared to baseline as well as the development of an expanded patient immune response against tumor via epitope spreading.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to 15 years</time_frame>
    <description>Will be observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>Up to 15 years</time_frame>
    <description>The median progression free survival and the corresponding 95% confidence interval will be calculated.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Recurrent Fallopian Tube Carcinoma</condition>
  <condition>Recurrent Ovarian Carcinoma</condition>
  <condition>Recurrent Primary Peritoneal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Treatment (decitabine, genetically modified T cells)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COURSE 1: Patients receive decitabine IV daily over 1 hour on days -8 to -6, cyclophosphamide IV over 2 hours on days -4 and -3, and genetically engineered NY-ESO-1-specific T lymphocytes IV and IP on day 0. Patients also receive aldesleukin SC BID on days 1-14..</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Aldesleukin</intervention_name>
    <description>Given SC</description>
    <arm_group_label>Treatment (decitabine, genetically modified T cells)</arm_group_label>
    <other_name>125-L-Serine-2-133-interleukin 2</other_name>
    <other_name>Proleukin</other_name>
    <other_name>r-serHuIL-2</other_name>
    <other_name>Recombinant Human IL-2</other_name>
    <other_name>Recombinant Human Interleukin-2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (decitabine, genetically modified T cells)</arm_group_label>
    <other_name>(-)-Cyclophosphamide</other_name>
    <other_name>2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate</other_name>
    <other_name>Carloxan</other_name>
    <other_name>Ciclofosfamida</other_name>
    <other_name>Ciclofosfamide</other_name>
    <other_name>Cicloxal</other_name>
    <other_name>Clafen</other_name>
    <other_name>Claphene</other_name>
    <other_name>CP monohydrate</other_name>
    <other_name>CTX</other_name>
    <other_name>CYCLO-cell</other_name>
    <other_name>Cycloblastin</other_name>
    <other_name>Cycloblastine</other_name>
    <other_name>Cyclophospham</other_name>
    <other_name>Cyclophosphamid monohydrate</other_name>
    <other_name>Cyclophosphamidum</other_name>
    <other_name>Cyclophosphan</other_name>
    <other_name>Cyclophosphane</other_name>
    <other_name>Cyclophosphanum</other_name>
    <other_name>Cyclostin</other_name>
    <other_name>Cyclostine</other_name>
    <other_name>Cytophosphan</other_name>
    <other_name>Cytophosphane</other_name>
    <other_name>Cytoxan</other_name>
    <other_name>Fosfaseron</other_name>
    <other_name>Genoxal</other_name>
    <other_name>Genuxal</other_name>
    <other_name>Ledoxina</other_name>
    <other_name>Mitoxan</other_name>
    <other_name>Neosar</other_name>
    <other_name>Revimmune</other_name>
    <other_name>Syklofosfamid</other_name>
    <other_name>WR- 138719</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decitabine</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (decitabine, genetically modified T cells)</arm_group_label>
    <other_name>5-Aza-2'-deoxycytidine</other_name>
    <other_name>Dacogen</other_name>
    <other_name>Decitabine for Injection</other_name>
    <other_name>Deoxyazacytidine</other_name>
    <other_name>Dezocitidine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Genetically Engineered NY-ESO-1-specific T Lymphocytes</intervention_name>
    <description>Given IV and IP</description>
    <arm_group_label>Treatment (decitabine, genetically modified T cells)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (decitabine, genetically modified T cells)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with recurrent or refractory epithelial or non-epithelial ovarian, primary&#xD;
             peritoneal or fallopian tube carcinoma who have received platinum containing&#xD;
             chemotherapy and either has platinum refractory or resistant disease, or if plantinum&#xD;
             sensitive disease, have received &gt;= 2 lines of chemotherapy. Subjects may have&#xD;
             received PARP inhibitators , bevacizumab or immunotherapy. Non-epithelial tumors of&#xD;
             the ovary include sarcomas, granulosa cell tumors and malignant germ cell tumors&#xD;
             including chiriocarcinoma&#xD;
&#xD;
          -  Have been informed of other treatment options&#xD;
&#xD;
          -  Must be HLA- A*02;01 positive; retesting is not required for patients who have&#xD;
             previous documented HLA-A*02;01 positivity&#xD;
&#xD;
          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          -  Life expectancy of &gt; 4 months&#xD;
&#xD;
          -  At least 4 weeks from prior chemotherapy, radiotherapy or immunotherapy, or prior&#xD;
             investigational agents&#xD;
&#xD;
          -  Must have measurable disease as defined by irRECIST&#xD;
&#xD;
          -  Must have adequate venous access for apheresis; (pheresis catheter placement for cell&#xD;
             collection is allowed)&#xD;
&#xD;
          -  Women of childbearing potential in agreement to use acceptable birth control methods&#xD;
             for the duration of the study and until persistence of the study drug is no longer&#xD;
             detected in the peripheral blood; this may be a period of several years; methods for&#xD;
             acceptable birth control include: condoms, diaphragm or cervical cap with spermicide,&#xD;
             intrauterine device, and hormonal contraception; it is recommended that a combination&#xD;
             of two methods be used&#xD;
&#xD;
          -  Leukocytes &gt;= 3 x 10^9/L&#xD;
&#xD;
          -  Absolute neutrophil count &gt;= 1 x 10^9/L&#xD;
&#xD;
          -  Platelets &gt;= 100 x 10^9/L&#xD;
&#xD;
          -  Total bilirubin within normal institutional limits&#xD;
&#xD;
          -  Aspartate Aminotransferases (AST) (serum glutamic-oxaloacetic transaminase&#xD;
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])&#xD;
             =&lt; 2.5 x institutional upper limit of normal&#xD;
&#xD;
          -  Creatinine level = 2X&lt; upper limit of normal (ULN): if creatinine &gt; 2XULN, creatinine&#xD;
             clearance must be &gt; 60ml/min&#xD;
&#xD;
          -  Patient must understand the investigational nature of this study and sign an&#xD;
             Independent Ethics Committee/Institutional Review Board approved written informed&#xD;
             consent form prior to receiving any study related procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving any other investigational agents&#xD;
&#xD;
          -  Patients with active brain metastases should be excluded from this clinical trial;&#xD;
             patients with prior history of brain metastasis who have undergone local therapy&#xD;
             (i.e., metastasectomy and/or radiation) and show no evidence of local recurrence or&#xD;
             progression over the past 6 months are eligible. Brain MRI as clinically indicated&#xD;
             only&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to cyclophosphamide, decitabine or other agents used in the study&#xD;
&#xD;
          -  Prior malignancy (except non melanoma skin cancer) within 3 years&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          -  Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g.,&#xD;
             interleukin 2, interferon alpha or gamma, granulocyte colony stimulating factors,&#xD;
             etc.) within 30 days prior to study entry&#xD;
&#xD;
               -  NOTE: recent or current use of inhaled steroids is not exclusionary; if subjects&#xD;
                  are prescribed a brief course of oral corticosteroids, the use should be limited&#xD;
                  to less than 7 days&#xD;
&#xD;
          -  Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV),&#xD;
             hepatitis C virus (HCV), or cytomegalovirus (CMV) as defined below, due to the&#xD;
             immunosuppressive effects of cyclophosphamide used and the unknown risks associated&#xD;
             with viral replication&#xD;
&#xD;
               -  Positive serology for HIV&#xD;
&#xD;
               -  Active hepatitis B infection as determined by a positive test for hepatitis B&#xD;
                  surface antigen (Ag)&#xD;
&#xD;
               -  Active hepatitis C; patients will be screened for HCV antibody; if the HCV&#xD;
                  antibody is positive, a screening HCV ribonucleic acid (RNA) by any real time&#xD;
                  polymerase chain reaction (RT PCR) or branched deoxyribose nucleic acid (bDNA)&#xD;
                  assay must be performed at screening by a local laboratory with a Clinical&#xD;
                  Laboratory Improvement Act (CLIA) certification or its equivalent; eligibility&#xD;
                  will be determined based on a negative screening value; the test is not required&#xD;
                  if documentation of a negative result of a HCV RNA test performed within 60 days&#xD;
                  prior to screening is provided&#xD;
&#xD;
               -  Serology (CMV immunoglobulin G [IgG]) positive for active CMV&#xD;
&#xD;
          -  Received any previous gene therapy using an integrating vector within 6 months&#xD;
&#xD;
          -  Pregnancy or breast-feeding&#xD;
&#xD;
          -  Lack of availability of a patient for immunological and clinical follow up assessment&#xD;
&#xD;
          -  Evidence or history of significant cardiac disease (including evidence or history of&#xD;
             significant cardiac disease (including myocardial infarction [MI] in the past 6&#xD;
             months, significant cardiac arrhythmia, stage III or IV congestive heart failure&#xD;
             [CHF]); cardiac stress test will be done as clinically indicated; (the specific test&#xD;
             to be chosen at the discretion of the principal investigator [PI])&#xD;
&#xD;
          -  Patients with pulmonary function test abnormalities as evidenced by a forced&#xD;
             expiratory volume in 1 second to forced vital capacity ratio measurement (FEV1/FVC) &lt;&#xD;
             70% of predicted for normality will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emese Zsiros, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Roswell Park Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>October 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>March 14, 2023</last_update_submitted>
  <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aldesleukin</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Decitabine</mesh_term>
    <mesh_term>Interleukin-2</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03017131
org study id: i 283616
secondary id: NCI-2016-01477
secondary id: i 283616
secondary id: P30CA016056
secondary id: P50CA159981
nct id: NCT03017131
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase I trial studies the side effects of genetically modified T cells and decitabine in
      treating patients with recurrent or refractory epithelial or non-epithelial ovarian, primary
      peritoneal, or fallopian tube cancer that has come back or has not responded to previous
      treatments. White blood cells called T cells are collected via a process called
      leukapheresis, genetically modified to recognize and attack tumor cells, then given back to
      the patient. Decitabine may induce and increase the amount of the target protein NY-ESO-1
      available on the surface of tumor cells. Giving genetically modified T cells and decitabine
      may kill more tumor cells.
PRIMARY OBJECTIVES:

      I. To determine the safety and tolerability of the autologous NY-ESO-1 redirected T cell
      therapy in combination with decitabine and low-dose IL-2 in patients with treatment
      refractory or recurrent epithelial or non-epithelial ovarian, primary peritoneal or fallopian
      tube carcinoma.

      SECONDARY OBJECTIVES:

      I. To evaluate the persistence of genetically modified cells in the peripheral blood, and at
      tumor sites.

      II. To examine the effect of the treatment on tumor as measured by objective tumor response
      and progression free survival, both assessed by immune-related Response Evaluation Criteria
      in Solid Tumors (irRECIST).

      III. To assess the occurrence of target antigen and/or major histocompatibality complex (MHC)
      loss variants upon disease recurrence.

      TERTIARY OBJECTIVES:

      I. To evaluate the post treatment phenotype and functionality of genetically modified T cells
      isolated from peripheral blood and from tumor sites.

      II. To assess changes in immunoscore, Tregs, Myeloid cell subsets, and antigen spreading in
      peripheral blood and tumor site.

      III. To assess the influence of demographic and disease molecular characteristics on
      treatment outcomes of complete response (CR) and overall survival (OS).

      OUTLINE:

      COURSE 1: Patients receive decitabine IV daily over 1 hour on days -8 to Day -6,
      cyclophosphamide IV over 2 hours on days -4 and -3, and genetically engineered
      NY-ESO-1-specific T lymphocytes IV and intraperitoneally (IP) on day 0. Followed by low-dose
      IL-2 for 2 weeks from Day 1 to Day 14..

      After completion of study treatment, patients are followed up monthly at 3-9 months, every 6
      months for 4 years, and then annually for up to 15 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events version 4
time frame: Up to 28 days post infusion
description: The frequency of toxicities will be tabulated by grade across all dose levels and cycles.
measure: Appearance of target antigen/major histocompatibility complex loss variants upon disease recurrence
time frame: Up to 15 years
description: Will be evaluated by quantifying expression of targeted antigens/major histocompatibility complex alleles (NY-ESO-1/human leukocyte antigen-A*02) in tumor samples obtained on disease recurrence if available, and comparing those values to the pretreatment (diagnosis) samples. NY-ESO-1 expression will be evaluated by quantitative real time polymerase chain reaction immunohistochemistry. Human leukocyte antigen-A*0201 expression on samples will be evaluated by immunohistochemistry.
measure: Clinical response rates
time frame: Up to 15 years
description: Percentage of complete and partial responses and the corresponding 95% confidence interval will be calculated.
measure: Duration of response
time frame: Up to 15 years
description: Will be observed.
measure: Immunological parameters associated with T cell persistence, bioactivity and functionality
time frame: Up to 15 years
description: Will measure the pre- and post-treatment percentage of transgenic T cells in the peripheral blood, selective migration into the tumor sites, the ex-vivo immune functionality and phenotype of these cells, the modulation of cytokine milieu in serum post treatment as compared to baseline as well as the development of an expanded patient immune response against tumor via epitope spreading.
measure: Overall survival
time frame: Up to 15 years
description: Will be observed.
measure: Progression free survival
time frame: Up to 15 years
description: The median progression free survival and the corresponding 95% confidence interval will be calculated.
arm group label: Treatment (decitabine, genetically modified T cells)
arm group type: Experimental
description: COURSE 1: Patients receive decitabine IV daily over 1 hour on days -8 to -6, cyclophosphamide IV over 2 hours on days -4 and -3, and genetically engineered NY-ESO-1-specific T lymphocytes IV and IP on day 0. Patients also receive aldesleukin SC BID on days 1-14..
intervention type: Biological
intervention name: Aldesleukin
description: Given SC
arm group label: Treatment (decitabine, genetically modified T cells)
other name: 125-L-Serine-2-133-interleukin 2
other name: Proleukin
other name: r-serHuIL-2
other name: Recombinant Human IL-2
other name: Recombinant Human Interleukin-2
intervention type: Drug
intervention name: Cyclophosphamide
description: Given IV
arm group label: Treatment (decitabine, genetically modified T cells)
other name: (-)-Cyclophosphamide
other name: 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
other name: Carloxan
other name: Ciclofosfamida
other name: Ciclofosfamide
other name: Cicloxal
other name: Clafen
other name: Claphene
other name: CP monohydrate
other name: CTX
other name: CYCLO-cell
other name: Cycloblastin
other name: Cycloblastine
other name: Cyclophospham
other name: Cyclophosphamid monohydrate
other name: Cyclophosphamidum
other name: Cyclophosphan
other name: Cyclophosphane
other name: Cyclophosphanum
other name: Cyclostin
other name: Cyclostine
other name: Cytophosphan
other name: Cytophosphane
other name: Cytoxan
other name: Fosfaseron
other name: Genoxal
other name: Genuxal
other name: Ledoxina
other name: Mitoxan
other name: Neosar
other name: Revimmune
other name: Syklofosfamid
other name: WR- 138719
intervention type: Drug
intervention name: Decitabine
description: Given IV
arm group label: Treatment (decitabine, genetically modified T cells)
other name: 5-Aza-2'-deoxycytidine
other name: Dacogen
other name: Decitabine for Injection
other name: Deoxyazacytidine
other name: Dezocitidine
intervention type: Biological
intervention name: Genetically Engineered NY-ESO-1-specific T Lymphocytes
description: Given IV and IP
arm group label: Treatment (decitabine, genetically modified T cells)
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Treatment (decitabine, genetically modified T cells)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emese Zsiros, MD
role: Principal Investigator
affiliation: Roswell Park Cancer Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Recurrence
mesh term: Aldesleukin
mesh term: Cyclophosphamide
mesh term: Decitabine
mesh term: Interleukin-2