Clinical Trials /

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

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

  • ORG STUDY ID: 2721.00
  • SECONDARY ID: NCI-2014-02154
  • SECONDARY ID: 2721
  • SECONDARY ID: 2721.00
  • SECONDARY ID: K23CA175167
  • SECONDARY ID: P30CA015704
  • NCT ID: NCT02319824

Conditions

  • Sarcoma

Interventions

DrugSynonymsArms
Autologous NY-ESO-1-specific CD8-positive T LymphocytesTreatment (radiation and NY-ESO-1-specific T cells)

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

NameTypeDescriptionInterventions
Treatment (radiation and NY-ESO-1-specific T cells)ExperimentalPatients 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.
  • Autologous NY-ESO-1-specific CD8-positive T Lymphocytes

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03
Time Frame:Up to 12 weeks post-treatment
Safety Issue:
Description:CTCAE v4.03

Secondary Outcome Measures

Measure:T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1
Time Frame:At 6 weeks post-treatment
Safety Issue:
Description:RECIST at 6 weeks after treatment (non-radiated tumors only)
Measure:Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers
Time Frame:Up to 6 weeks post-treatment
Safety Issue:
Description:Over 5% tet+ cells at 6 weeks? Patients may have detectable NY-ESO-1 specific T cells by MHC tetramers but if they are less than 5% this will be considered negative.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Fred Hutchinson Cancer Research Center

Last Updated

July 5, 2017