<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/NCT03017820</url>
  </required_header>
  <id_info>
    <org_study_id>MC1684</org_study_id>
    <secondary_id>NCI-2017-00049</secondary_id>
    <secondary_id>MC1684</secondary_id>
    <secondary_id>P30CA015083</secondary_id>
    <secondary_id>16-005474</secondary_id>
    <nct_id>NCT03017820</nct_id>
  </id_info>
  <brief_title>VSV-hIFNbeta-NIS in Treating Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma</brief_title>
  <official_title>Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, Lymphomas, or Histiocytic/Dendritic Cell Neoplasms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</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 best dose and side effects of recombinant vesicular stomatitis&#xD;
      virus carrying the human NIS and IFN beta genes (VSV-hIFNbeta-sodium iodide symporter [NIS])&#xD;
      with or without cyclophosphamide or ipilimumab and nivolumab in treating patients with&#xD;
      multiple myeloma, acute myeloid leukemia (AML) or lymphoma that has come back or does not&#xD;
      respond to treatment. A virus, called VSV-hIFNbeta-NIS, which has been changed in a certain&#xD;
      way, may be able to kill cancer cells without damaging normal cells. Cyclophosphamide is in a&#xD;
      class of medications called alkylating agents. It works by damaging the cell's DNA and may&#xD;
      kill cancer cells. It may also lower the body's immune response. Immunotherapy with ipilmumab&#xD;
      and nivolumab may induce changes in body's immune system and may interfere with the ability&#xD;
      of tumor cells to grow and spread. Giving VSV-hIFNbeta-NIS and ruxolitinib phosphate may work&#xD;
      better at treating multiple myeloma, acute myeloid leukemia and T-cell lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To determine the maximum tolerated dose (MTD) of VSV-hIFNβ-NIS in different treatment&#xD;
      regimens (alone [Group A, F, G] in combination with ruxolitinib [Group B] and in combination&#xD;
      with cyclophosphamide [Group C]) in patients with relapsed/refractory multiple myeloma, acute&#xD;
      myeloid leukemia, T and B-cell lymphoma, or histiocytic/dendritic cell neoplasms; in&#xD;
      combination with ipilimumab and nivolumab in patients with multiple myeloma [Group D] and in&#xD;
      patients with T-cell lymphoma [Group E].&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the safety profile of VSV-hIFNbeta-NIS (alone and in combination).&#xD;
&#xD;
      II. To estimate clinical response rate of VSV-hIFNbeta-NIS (alone and in combination) in&#xD;
      patients with relapsed/refractory multiple myeloma, acute myeloid leukemia, T-cell and B-cell&#xD;
      lymphoma or histiocytic/dendritic cell neoplasms overall and by disease type.&#xD;
&#xD;
      III. To estimate progression-free and overall survival of VSV-hIFNbeta-NIS (alone and in&#xD;
      combination) in patients with relapsed/refractory multiple myeloma, acute myeloid leukemia, T&#xD;
      and B-cell lymphoma, or histiocytic/dendritic cell neoplasms overall and by disease type.&#xD;
&#xD;
      CORRELATIVE OBJECTIVES:&#xD;
&#xD;
      I. To determine the time course of viral gene expression and virus elimination, and the&#xD;
      biodistribution of virally infected cells at various times points after infection with&#xD;
      VSV-hIFNbeta-NIS using planar and single photon emission computed tomography (SPECT)/computed&#xD;
      tomography (CT) imaging.&#xD;
&#xD;
      II. To assess virus replication, viremia, viral shedding in urine and respiratory secretions,&#xD;
      and virus persistence after systemic administration of VSV-hIFNbeta-NIS.&#xD;
&#xD;
      III. To characterize the pharmacodynamics (PD) of VSV-IFNbeta-NIS by way of measuring serum&#xD;
      interferon-beta and also vesicular stomatitis virus (VSV)-real time (RT)-polymerase chain&#xD;
      reaction (PCR) of VSV-IFNbeta-NIS.&#xD;
&#xD;
      IV. Assess CD8+ T cell (both general and VSV-IFNbeta-NIS specific) and natural killer (NK)&#xD;
      cell responses.&#xD;
&#xD;
      V. Gene expression analysis pre- and post-virotherapy. VI. Assess presence of VSV in tumor&#xD;
      and normal tissues subsequent to administration of intravenous (IV) VSV-IFNbeta-NIS.&#xD;
&#xD;
      VII. To identify the best dose of VSV-hIFNbeta-NIS in the regimen being evaluated based on&#xD;
      activity observed in the correlative measures described above in those dose levels identified&#xD;
      as tolerable.&#xD;
&#xD;
      OUTLINE: This is a dose escalation study of VSV-IFNbeta-NIS. Patients are assigned to 1 of 3&#xD;
      groups.&#xD;
&#xD;
      GROUP A: Patients receive VSV-IFNbeta-NIS intravenously (IV) while on study.&#xD;
&#xD;
      GROUP B: Patients receive VSV-IFNbeta-NIS IV and cyclophosphamide IV while on study.&#xD;
&#xD;
      GROUP C: Patients receive VSV-IFNbeta-NIS IV, ipilimumab IV and nivolumab IV while on study.&#xD;
&#xD;
      Patients undergo computed tomography (CT) scan, position emission tomography (PET) scan&#xD;
      throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample&#xD;
      collection throughout the study.&#xD;
&#xD;
      After completion of study treatment, patients are followed up for 28 days, and then every 3&#xD;
      months for up to 1 year or until progressive disease, then every 6 months for 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 4, 2017</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events of grade 3 or higher</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Assessed by the Common Terminology Criteria for Adverse Events version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns (by cohort and overall). Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The rate of grade 3 or higher non-hematologic adverse events, and the rate of grade 4 or higher adverse event (hematologic and non-hematologic) will be computed each with a 95% exact binomial confidence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical response</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>The number of responses (complete response [CR], very good partial response, partial response [PR], or minimal response for multiple myeloma; CR, CR with incomplete recovery, cytogenetic complete response, PR for acute myeloid leukemia [AML]; CR or PR for T-cell lymphoma [TCL]) will be summarized by simple descriptive summary statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>From registration to disease progression or death due to any cause, assessed up to 2 years</time_frame>
    <description>The distribution of survival time will be estimated using the method of Kaplan-Meier (overall, by dose level, and by disease type).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From registration to death due to any cause, assessed up to 2 years</time_frame>
    <description>The distribution of survival time will be estimated using the method of Kaplan-Meier (overall, by dose level, and by disease type).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Biodistribution and kinetics of virus spread</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Assessed by single photon emission computed tomography (SPECT)/computed tomography (CT) imaging. Descriptive statistics and scatterplots will form the basis of presentation of these variables. Correlations between the laboratory values and other outcome measures will be carried out by standard parametric and non-parametric tests (e.g., Pearson's and Spearman's rho). Will be correlated with tumor distribution.</description>
  </other_outcome>
  <other_outcome>
    <measure>NIS gene expression in tumor samples</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Assessed by single photon emission computed tomography (SPECT)/computed tomography (CT) imaging. Descriptive statistics and scatterplots will form the basis of presentation of these variables. Correlations between the laboratory values and other outcome measures will be carried out by standard parametric and non-parametric tests (e.g., Pearson's and Spearman's rho). Will be correlated with tumor distribution.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>B-Cell Non-Hodgkin Lymphoma</condition>
  <condition>Histiocytic and Dendritic Cell Neoplasm</condition>
  <condition>Myelodysplastic Syndrome</condition>
  <condition>Previously Treated Myelodysplastic Syndrome</condition>
  <condition>Recurrent Adult Acute Myeloid Leukemia</condition>
  <condition>Recurrent Anaplastic Large Cell Lymphoma</condition>
  <condition>Recurrent Angioimmunoblastic T-Cell Lymphoma</condition>
  <condition>Recurrent Mycosis Fungoides</condition>
  <condition>Recurrent Plasma Cell Myeloma</condition>
  <condition>Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma</condition>
  <condition>Recurrent T-Cell Non-Hodgkin Lymphoma</condition>
  <condition>Refractory Acute Myeloid Leukemia</condition>
  <condition>Refractory Anaplastic Large Cell Lymphoma</condition>
  <condition>Refractory Angioimmunoblastic T-Cell Lymphoma</condition>
  <condition>Refractory Mycosis Fungoides</condition>
  <condition>Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified</condition>
  <condition>Refractory Plasma Cell Myeloma</condition>
  <condition>Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma</condition>
  <condition>Refractory T-Cell Non-Hodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>Group A (VSV-IFNbeta-NIS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive VSV-IFNbeta-NIS intravenously (IV) while on study. Patients undergo SPECT, CT scan, PET scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B (VSV-IFNbeta-NIS, ruxolitinib)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive VSV-IFNbeta-NIS IV and cyclophosphamide IV while on study. Patients undergo SPECT, CT scan, PET scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive VSV-IFNbeta-NIS IV, ipilimumab IV and nivolumab IV while on study. Patients undergo SPECT, CT scan, PET scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biopsy</intervention_name>
    <description>Undergo tumor biopsy</description>
    <arm_group_label>Group A (VSV-IFNbeta-NIS)</arm_group_label>
    <arm_group_label>Group B (VSV-IFNbeta-NIS, ruxolitinib)</arm_group_label>
    <arm_group_label>Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)</arm_group_label>
    <other_name>BIOPSY_TYPE</other_name>
    <other_name>Bx</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Undergo blood sample collection</description>
    <arm_group_label>Group A (VSV-IFNbeta-NIS)</arm_group_label>
    <arm_group_label>Group B (VSV-IFNbeta-NIS, ruxolitinib)</arm_group_label>
    <arm_group_label>Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)</arm_group_label>
    <other_name>Biological Sample Collection</other_name>
    <other_name>Biospecimen Collected</other_name>
    <other_name>Specimen Collection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bone Marrow Biopsy</intervention_name>
    <description>Undergo bone marrow biopsy</description>
    <arm_group_label>Group A (VSV-IFNbeta-NIS)</arm_group_label>
    <arm_group_label>Group B (VSV-IFNbeta-NIS, ruxolitinib)</arm_group_label>
    <arm_group_label>Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)</arm_group_label>
    <other_name>Biopsy of Bone Marrow</other_name>
    <other_name>Biopsy, Bone Marrow</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Computed Tomography</intervention_name>
    <description>Undergo SPECT/CT</description>
    <arm_group_label>Group A (VSV-IFNbeta-NIS)</arm_group_label>
    <arm_group_label>Group B (VSV-IFNbeta-NIS, ruxolitinib)</arm_group_label>
    <arm_group_label>Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)</arm_group_label>
    <other_name>CAT</other_name>
    <other_name>CAT Scan</other_name>
    <other_name>Computed Axial Tomography</other_name>
    <other_name>Computerized Axial Tomography</other_name>
    <other_name>Computerized axial tomography (procedure)</other_name>
    <other_name>Computerized Tomography</other_name>
    <other_name>CT</other_name>
    <other_name>CT Scan</other_name>
    <other_name>tomography</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Group B (VSV-IFNbeta-NIS, ruxolitinib)</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>Cyclophosphamide 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>Biological</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)</arm_group_label>
    <other_name>Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody</other_name>
    <other_name>BMS-734016</other_name>
    <other_name>Ipilimumab Biosimilar CS1002</other_name>
    <other_name>MDX-010</other_name>
    <other_name>MDX-CTLA4</other_name>
    <other_name>Yervoy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)</arm_group_label>
    <other_name>BMS-936558</other_name>
    <other_name>CMAB819</other_name>
    <other_name>MDX-1106</other_name>
    <other_name>NIVO</other_name>
    <other_name>Nivolumab Biosimilar CMAB819</other_name>
    <other_name>ONO-4538</other_name>
    <other_name>Opdivo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Positron Emission Tomography</intervention_name>
    <description>Undergo PET scan</description>
    <arm_group_label>Group A (VSV-IFNbeta-NIS)</arm_group_label>
    <arm_group_label>Group B (VSV-IFNbeta-NIS, ruxolitinib)</arm_group_label>
    <arm_group_label>Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)</arm_group_label>
    <other_name>Medical Imaging, Positron Emission Tomography</other_name>
    <other_name>PET</other_name>
    <other_name>PET Scan</other_name>
    <other_name>Positron emission tomography (procedure)</other_name>
    <other_name>Positron Emission Tomography Scan</other_name>
    <other_name>Positron-Emission Tomography</other_name>
    <other_name>proton magnetic resonance spectroscopic imaging</other_name>
    <other_name>PT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Group A (VSV-IFNbeta-NIS)</arm_group_label>
    <arm_group_label>Group B (VSV-IFNbeta-NIS, ruxolitinib)</arm_group_label>
    <arm_group_label>Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)</arm_group_label>
    <other_name>Oncolytic VSV-hIFNbeta-NIS</other_name>
    <other_name>Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter</other_name>
    <other_name>Voyager-V1</other_name>
    <other_name>VSV-expressing hIFNb and NIS</other_name>
    <other_name>VSV-hIFNb-NIS</other_name>
    <other_name>VSV-hIFNbeta-NIS</other_name>
    <other_name>VV1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Single Photon Emission Computed Tomography</intervention_name>
    <description>Undergo SPECT/CT</description>
    <arm_group_label>Group A (VSV-IFNbeta-NIS)</arm_group_label>
    <arm_group_label>Group B (VSV-IFNbeta-NIS, ruxolitinib)</arm_group_label>
    <arm_group_label>Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)</arm_group_label>
    <other_name>Medical Imaging, Single Photon Emission Computed Tomography</other_name>
    <other_name>Single Photon Emission Tomography</other_name>
    <other_name>Single-Photon Emission Computed</other_name>
    <other_name>single-photon emission computed tomography</other_name>
    <other_name>SPECT</other_name>
    <other_name>SPECT imaging</other_name>
    <other_name>SPECT SCAN</other_name>
    <other_name>SPET</other_name>
    <other_name>ST</other_name>
    <other_name>tomography, emission computed, single photon</other_name>
    <other_name>Tomography, Emission-Computed, Single-Photon</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;= 18 years&#xD;
&#xD;
          -  Relapsed or refractory:&#xD;
&#xD;
               -  Groups A, B, C or D: Multiple myeloma (MM) previously treated with an&#xD;
                  immunomodulatory imide drug (IMID), a proteosome inhibitor, and an alkylating&#xD;
                  agent&#xD;
&#xD;
               -  Groups A, B, C only: Relapsed peripheral T-cell lymphoma (PTCL) of the following&#xD;
                  histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); angioimmunoblastic T-cell&#xD;
                  lymphoma (AITL), anaplastic large cell (ALCL), and mycosis fungoides (MF).&#xD;
                  Patients should have failed standard therapy and in the case of PTCL-NOS, AITL,&#xD;
                  and ALCL either have failed or be ineligible for high-dose therapy with&#xD;
                  autologous stem cell transplant&#xD;
&#xD;
               -  Group B and C only: B-cell lymphoma (other than Burkitt's lymphoma), or&#xD;
                  histiocytic/dendritic cell neoplasms (HCN) at any stage&#xD;
&#xD;
               -  Group E only: Relapsed peripheral T-cell lymphoma (PTCL) of the following&#xD;
                  histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); anaplastic large cell&#xD;
                  (ALCL), and mycosis fungoides (MF)&#xD;
&#xD;
               -  Group F only: Expansion Cohort for B-cell lymphoma (other than Burkitt's&#xD;
                  lymphoma) with low tumor burden&#xD;
&#xD;
               -  Group G only: Expansion Cohort for peripheral T cell lymphoma (PTCL) with low&#xD;
                  tumor burden&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =&lt; 2 times upper&#xD;
             limit of normal (ULN) (obtained =&lt; 15 days prior to registration)&#xD;
&#xD;
          -  Creatinine =&lt; 2.0 mg/dL (obtained =&lt; 15 days prior to registration)&#xD;
&#xD;
          -  Direct bilirubin =&lt; 1.5 x ULN (obtained =&lt; 15 days prior to registration)&#xD;
&#xD;
          -  International normalized ratio (INR)/prothrombin time (PT) and activated partial&#xD;
             thromboplastin time (aPTT) =&lt; 1.5 x ULN (obtained =&lt; 15 days prior to registration)&#xD;
&#xD;
          -  If baseline liver disease, Child Pugh score not exceeding class A (obtained =&lt; 15 days&#xD;
             prior to registration)&#xD;
&#xD;
          -  Negative pregnancy test for persons of child-bearing potential (obtained =&lt; 15 days&#xD;
             prior to registration)&#xD;
&#xD;
          -  FOR MULTIPLE MYELOMA ONLY: Measurable disease of multiple myeloma as defined by at&#xD;
             least ONE of the following:&#xD;
&#xD;
               -  Serum monoclonal protein &gt;= 1.0 g/dL by protein electrophoresis&#xD;
&#xD;
               -  &gt;= 200 mg of monoclonal protein in the urine on 24-hour electrophoresis&#xD;
&#xD;
               -  Serum immunoglobulin free light chain &gt;= 10 mg/dL AND abnormal serum&#xD;
                  immunoglobulin kappa to lambda free light chain ratio&#xD;
&#xD;
          -  FOR MULTIPLE MYELOMA ONLY: Absolute neutrophil count (ANC) &gt;= 1000/uL (obtained =&lt; 14&#xD;
             days prior to registration)&#xD;
&#xD;
          -  FOR MULTIPLE MYELOMA ONLY: Platelet (PLT) &gt;= 100,000/uL (obtained =&lt; 14 days prior to&#xD;
             registration)&#xD;
&#xD;
          -  FOR MULTIPLE MYELOMA ONLY: Hemoglobin &gt;= 8.5 g/dl (obtained =&lt; 14 days prior to&#xD;
             registration)&#xD;
&#xD;
          -  FOR AML ONLY: No ANC restriction (obtained =&lt; 14 days prior to registration)&#xD;
&#xD;
          -  FOR AML ONLY: PLT &gt;= 10,000/uL (transfusion to get platelets &gt;= 10,000 is allowed)&#xD;
             (obtained =&lt; 14 days prior to registration)&#xD;
&#xD;
          -  FOR AML ONLY: Hemoglobin &gt;= 7.5 g/dl (obtained =&lt; 14 days prior to registration)&#xD;
&#xD;
          -  FOR AML ONLY: Absence of uncompensated disseminated intravascular coagulation (DIC- as&#xD;
             diagnosed by standard International Society on Thrombosis and Hemostasis [ISTH]&#xD;
             criteria)&#xD;
&#xD;
          -  FOR TCL/BCL ONLY: ANC &gt;= 1,000/uL (obtained =&lt; 14 days prior to registration)&#xD;
&#xD;
          -  FOR TCL/BCL ONLY: PLT &gt;= 100,000/uL (obtained =&lt; 14 days prior to registration)&#xD;
&#xD;
          -  FOR TCL/BCL ONLY: Hemoglobin &gt;= 8.5 g/dl (obtained =&lt; 14 days prior to registration)&#xD;
&#xD;
          -  FOR TCL/BCL ONLY: Measurable disease by CT or magnetic resonance imaging (MRI): must&#xD;
             have at least one lesion that has a single diameter of &gt; 2 cm or tumor cells in the&#xD;
             blood &gt; 5 x 10^9/L; NOTE: skin lesions can be used if the area is &gt; 2 cm in at least&#xD;
             one diameter and photographed with a ruler and the images are available in the medical&#xD;
             record&#xD;
&#xD;
          -  FOR HCN ONLY: ANC &gt;= 1,000/uL obtained =&lt; 15 days prior to registration&#xD;
&#xD;
          -  FOR HCN ONLY: PLT &gt;= 100,000/uL obtained =&lt; 15 days prior to registration&#xD;
&#xD;
          -  FOR HCN ONLY: Hemoglobin &gt;= 8.0 g/dl obtained =&lt; 15 days prior to registration&#xD;
&#xD;
          -  FOR HCN ONLY: Measurable disease by CT or MRI: Must have at least one lesion that has&#xD;
             a single diameter of &gt;= 1.5 cm or tumor cells in the blood &gt;5 x10^9/L. NOTE: Skin&#xD;
             lesions can be used if the area is &gt;= 1.5 cm in at least one diameter and photographed&#xD;
             with a ruler and the images are available in the medical record&#xD;
&#xD;
          -  Absence of active central nervous system (CNS) involvement; NOTE: pre-enrollment&#xD;
             lumbar puncture not mandatory&#xD;
&#xD;
          -  Ability to provide written informed consent&#xD;
&#xD;
          -  Willingness to return to Mayo Clinic for follow-up&#xD;
&#xD;
          -  Life expectancy &gt;= 12 weeks&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2&#xD;
&#xD;
          -  Willing to provide mandatory biological specimens for research purposes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Availability of and patient acceptance of curative therapy&#xD;
&#xD;
          -  Uncontrolled infection&#xD;
&#xD;
          -  Active tuberculosis or hepatitis, or chronic hepatitis&#xD;
&#xD;
          -  Any of the following prior therapies:&#xD;
&#xD;
               -  Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =&lt; 2 weeks prior&#xD;
                  to registration&#xD;
&#xD;
               -  Immunotherapy (monoclonal antibodies) =&lt; 4 weeks prior to registration&#xD;
&#xD;
               -  Experimental agent in case of AML or TCL within 4 half-lives of the last dose of&#xD;
                  the agent&#xD;
&#xD;
          -  New York Heart Association classification III or IV, known symptomatic coronary artery&#xD;
             disease, or symptoms of coronary artery disease on systems review, or known cardiac&#xD;
             arrhythmias (atrial fibrillation or supraventricular tachycardia [SVT])&#xD;
&#xD;
          -  Active CNS disorder or seizure disorder or known CNS disease or neurologic&#xD;
             symptomatology; in case of AML active CNS involvement as detected by lumbar puncture&#xD;
             or neuro-imaging (only to be done if clinically indicated)&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or&#xD;
             immunosuppression&#xD;
&#xD;
          -  Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy&#xD;
             considered investigational (used for a non-Food and Drug Administration [FDA] approved&#xD;
             indication and in the context of a research investigation);&#xD;
&#xD;
               -  NOTE: in AML, the concurrent use of hydroxyurea to help control proliferative&#xD;
                  counts is allowed throughout the treatment protocol;&#xD;
&#xD;
               -  NOTE: in TCL, patients may use topical emollients or corticosteroids, acetic acid&#xD;
                  soaks, etc. to control pruritis and prevent infection; no topical chemotherapy is&#xD;
                  allowed (no topical nitrogen mustard)&#xD;
&#xD;
          -  Any of the following because this study involves an investigational agent whose&#xD;
             genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are&#xD;
             unknown:&#xD;
&#xD;
               -  Pregnant women or women of reproductive ability who are unwilling to use&#xD;
                  effective contraception&#xD;
&#xD;
               -  Nursing women&#xD;
&#xD;
               -  Men who are unwilling to use a condom (even if they have undergone a prior&#xD;
                  vasectomy) while having intercourse with any woman, while taking the drug and for&#xD;
                  4 weeks after stopping treatment&#xD;
&#xD;
          -  AML ONLY: Current disseminated intravascular coagulopathy (DIC)&#xD;
&#xD;
          -  ADDITIONAL EXCLUSION CRITERIA FOR GROUP A (LOW TUMOR BURDEN) ONLY:&#xD;
&#xD;
               -  Diagnosis of AML&#xD;
&#xD;
               -  Multiple myeloma only: &gt; 25% plasma cells or plasmacytoma &gt; 5cm in largest&#xD;
                  diameter&#xD;
&#xD;
               -  Lymphoma or HCN only: Any mass &gt;5cm&#xD;
&#xD;
               -  Diagnosis of Burkitt's lymphoma&#xD;
&#xD;
          -  ADDITIONAL EXCLUSION CRITERIA FOR GROUP B (HIGH TUMOR BURDEN) ONLY:&#xD;
&#xD;
               -  Diagnosis of AML&#xD;
&#xD;
               -  Diagnosis of Burkitt's lymphoma&#xD;
&#xD;
          -  ADDITIONAL EXCLUSION CRITERIA FOR GROUP C (COMBINATION WITH CYCLOPHOSPHAMIDE) ONLY:&#xD;
&#xD;
               -  Diagnosis of AML&#xD;
&#xD;
               -  Diagnosis of Burkitt's lymphoma&#xD;
&#xD;
          -  ADDITIONAL EXCLUSION CRITERIA FOR GROUP D AND E (COMBINATION WITH IPILIMUMAB AND&#xD;
             NIVOLUMAB) ONLY:&#xD;
&#xD;
               -  Diagnosis of AML&#xD;
&#xD;
               -  Diagnosis of AITL&#xD;
&#xD;
               -  Hypersensitivity to ipilimumab or its excipients&#xD;
&#xD;
          -  ADDITIONAL EXCLUSION CRITERIA FOR GROUP F (BCL EXPANSION COHORT) ONLY:&#xD;
&#xD;
               -  Diagnosis of Burkitt's lymphoma&#xD;
&#xD;
          -  ADDITIONAL EXCLUSION CRITERIA FOR GROUP G (PTCL EXPANSION COHORT) ONLY:&#xD;
&#xD;
               -  Diagnosis of cutaneous TCL&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martha Q Lacy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic in Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-776-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Javier L. Munoz, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-776-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Martha Q. Lacy, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Cook J, Peng KW, Witzig TE, Broski SM, Villasboas JC, Paludo J, Patnaik M, Rajkumar V, Dispenzieri A, Leung N, Buadi F, Bennani N, Ansell SM, Zhang L, Packiriswamy N, Balakrishnan B, Brunton B, Giers M, Ginos B, Dueck AC, Geyer S, Gertz MA, Warsame R, Go RS, Hayman SR, Dingli D, Kumar S, Bergsagel L, Munoz JL, Gonsalves W, Kourelis T, Muchtar E, Kapoor P, Kyle RA, Lin Y, Siddiqui M, Fonder A, Hobbs M, Hwa L, Naik S, Russell SJ, Lacy MQ. Clinical activity of single-dose systemic oncolytic VSV virotherapy in patients with relapsed refractory T-cell lymphoma. Blood Adv. 2022 Jun 14;6(11):3268-3279. doi: 10.1182/bloodadvances.2021006631.</citation>
    <PMID>35175355</PMID>
  </results_reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 9, 2017</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>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 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>Mycoses</mesh_term>
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
    <mesh_term>Mycosis Fungoides</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Cutaneous</mesh_term>
    <mesh_term>Lymphoma, Large-Cell, Anaplastic</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Immunoblastic Lymphadenopathy</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iodine</mesh_term>
    <mesh_term>Interferons</mesh_term>
    <mesh_term>Interferon-beta</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Ipilimumab</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/NCT03017820
org study id: MC1684
secondary id: NCI-2017-00049
secondary id: MC1684
secondary id: P30CA015083
secondary id: 16-005474
nct id: NCT03017820
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis
      virus carrying the human NIS and IFN beta genes (VSV-hIFNbeta-sodium iodide symporter [NIS])
      with or without cyclophosphamide or ipilimumab and nivolumab in treating patients with
      multiple myeloma, acute myeloid leukemia (AML) or lymphoma that has come back or does not
      respond to treatment. A virus, called VSV-hIFNbeta-NIS, which has been changed in a certain
      way, may be able to kill cancer cells without damaging normal cells. Cyclophosphamide is in a
      class of medications called alkylating agents. It works by damaging the cell's DNA and may
      kill cancer cells. It may also lower the body's immune response. Immunotherapy with ipilmumab
      and nivolumab may induce changes in body's immune system and may interfere with the ability
      of tumor cells to grow and spread. Giving VSV-hIFNbeta-NIS and ruxolitinib phosphate may work
      better at treating multiple myeloma, acute myeloid leukemia and T-cell lymphoma.
PRIMARY OBJECTIVE:

      I. To determine the maximum tolerated dose (MTD) of VSV-hIFNβ-NIS in different treatment
      regimens (alone [Group A, F, G] in combination with ruxolitinib [Group B] and in combination
      with cyclophosphamide [Group C]) in patients with relapsed/refractory multiple myeloma, acute
      myeloid leukemia, T and B-cell lymphoma, or histiocytic/dendritic cell neoplasms; in
      combination with ipilimumab and nivolumab in patients with multiple myeloma [Group D] and in
      patients with T-cell lymphoma [Group E].

      SECONDARY OBJECTIVES:

      I. To determine the safety profile of VSV-hIFNbeta-NIS (alone and in combination).

      II. To estimate clinical response rate of VSV-hIFNbeta-NIS (alone and in combination) in
      patients with relapsed/refractory multiple myeloma, acute myeloid leukemia, T-cell and B-cell
      lymphoma or histiocytic/dendritic cell neoplasms overall and by disease type.

      III. To estimate progression-free and overall survival of VSV-hIFNbeta-NIS (alone and in
      combination) in patients with relapsed/refractory multiple myeloma, acute myeloid leukemia, T
      and B-cell lymphoma, or histiocytic/dendritic cell neoplasms overall and by disease type.

      CORRELATIVE OBJECTIVES:

      I. To determine the time course of viral gene expression and virus elimination, and the
      biodistribution of virally infected cells at various times points after infection with
      VSV-hIFNbeta-NIS using planar and single photon emission computed tomography (SPECT)/computed
      tomography (CT) imaging.

      II. To assess virus replication, viremia, viral shedding in urine and respiratory secretions,
      and virus persistence after systemic administration of VSV-hIFNbeta-NIS.

      III. To characterize the pharmacodynamics (PD) of VSV-IFNbeta-NIS by way of measuring serum
      interferon-beta and also vesicular stomatitis virus (VSV)-real time (RT)-polymerase chain
      reaction (PCR) of VSV-IFNbeta-NIS.

      IV. Assess CD8+ T cell (both general and VSV-IFNbeta-NIS specific) and natural killer (NK)
      cell responses.

      V. Gene expression analysis pre- and post-virotherapy. VI. Assess presence of VSV in tumor
      and normal tissues subsequent to administration of intravenous (IV) VSV-IFNbeta-NIS.

      VII. To identify the best dose of VSV-hIFNbeta-NIS in the regimen being evaluated based on
      activity observed in the correlative measures described above in those dose levels identified
      as tolerable.

      OUTLINE: This is a dose escalation study of VSV-IFNbeta-NIS. Patients are assigned to 1 of 3
      groups.

      GROUP A: Patients receive VSV-IFNbeta-NIS intravenously (IV) while on study.

      GROUP B: Patients receive VSV-IFNbeta-NIS IV and cyclophosphamide IV while on study.

      GROUP C: Patients receive VSV-IFNbeta-NIS IV, ipilimumab IV and nivolumab IV while on study.

      Patients undergo computed tomography (CT) scan, position emission tomography (PET) scan
      throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample
      collection throughout the study.

      After completion of study treatment, patients are followed up for 28 days, and then every 3
      months for up to 1 year or until progressive disease, then every 6 months for 1 year.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of adverse events of grade 3 or higher
time frame: Up to 2 years
description: Assessed by the Common Terminology Criteria for Adverse Events version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns (by cohort and overall). Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The rate of grade 3 or higher non-hematologic adverse events, and the rate of grade 4 or higher adverse event (hematologic and non-hematologic) will be computed each with a 95% exact binomial confidence.
measure: Clinical response
time frame: Up to 2 years
description: The number of responses (complete response [CR], very good partial response, partial response [PR], or minimal response for multiple myeloma; CR, CR with incomplete recovery, cytogenetic complete response, PR for acute myeloid leukemia [AML]; CR or PR for T-cell lymphoma [TCL]) will be summarized by simple descriptive summary statistics.
measure: Progression-free survival
time frame: From registration to disease progression or death due to any cause, assessed up to 2 years
description: The distribution of survival time will be estimated using the method of Kaplan-Meier (overall, by dose level, and by disease type).
measure: Overall survival
time frame: From registration to death due to any cause, assessed up to 2 years
description: The distribution of survival time will be estimated using the method of Kaplan-Meier (overall, by dose level, and by disease type).
measure: Biodistribution and kinetics of virus spread
time frame: Up to 2 years
description: Assessed by single photon emission computed tomography (SPECT)/computed tomography (CT) imaging. Descriptive statistics and scatterplots will form the basis of presentation of these variables. Correlations between the laboratory values and other outcome measures will be carried out by standard parametric and non-parametric tests (e.g., Pearson's and Spearman's rho). Will be correlated with tumor distribution.
measure: NIS gene expression in tumor samples
time frame: Up to 2 years
description: Assessed by single photon emission computed tomography (SPECT)/computed tomography (CT) imaging. Descriptive statistics and scatterplots will form the basis of presentation of these variables. Correlations between the laboratory values and other outcome measures will be carried out by standard parametric and non-parametric tests (e.g., Pearson's and Spearman's rho). Will be correlated with tumor distribution.
arm group label: Group A (VSV-IFNbeta-NIS)
arm group type: Experimental
description: Patients receive VSV-IFNbeta-NIS intravenously (IV) while on study. Patients undergo SPECT, CT scan, PET scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study.
arm group label: Group B (VSV-IFNbeta-NIS, ruxolitinib)
arm group type: Experimental
description: Patients receive VSV-IFNbeta-NIS IV and cyclophosphamide IV while on study. Patients undergo SPECT, CT scan, PET scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study.
arm group label: Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)
arm group type: Experimental
description: Patients receive VSV-IFNbeta-NIS IV, ipilimumab IV and nivolumab IV while on study. Patients undergo SPECT, CT scan, PET scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study.
intervention type: Procedure
intervention name: Biopsy
description: Undergo tumor biopsy
arm group label: Group A (VSV-IFNbeta-NIS)
arm group label: Group B (VSV-IFNbeta-NIS, ruxolitinib)
arm group label: Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)
other name: BIOPSY_TYPE
other name: Bx
intervention type: Procedure
intervention name: Biospecimen Collection
description: Undergo blood sample collection
arm group label: Group A (VSV-IFNbeta-NIS)
arm group label: Group B (VSV-IFNbeta-NIS, ruxolitinib)
arm group label: Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)
other name: Biological Sample Collection
other name: Biospecimen Collected
other name: Specimen Collection
intervention type: Procedure
intervention name: Bone Marrow Biopsy
description: Undergo bone marrow biopsy
arm group label: Group A (VSV-IFNbeta-NIS)
arm group label: Group B (VSV-IFNbeta-NIS, ruxolitinib)
arm group label: Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)
other name: Biopsy of Bone Marrow
other name: Biopsy, Bone Marrow
intervention type: Procedure
intervention name: Computed Tomography
description: Undergo SPECT/CT
arm group label: Group A (VSV-IFNbeta-NIS)
arm group label: Group B (VSV-IFNbeta-NIS, ruxolitinib)
arm group label: Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)
other name: CAT
other name: CAT Scan
other name: Computed Axial Tomography
other name: Computerized Axial Tomography
other name: Computerized axial tomography (procedure)
other name: Computerized Tomography
other name: CT
other name: CT Scan
other name: tomography
intervention type: Drug
intervention name: Cyclophosphamide
description: Given IV
arm group label: Group B (VSV-IFNbeta-NIS, ruxolitinib)
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: Cyclophosphamide 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: Biological
intervention name: Ipilimumab
description: Given IV
arm group label: Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)
other name: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
other name: BMS-734016
other name: Ipilimumab Biosimilar CS1002
other name: MDX-010
other name: MDX-CTLA4
other name: Yervoy
intervention type: Biological
intervention name: Nivolumab
description: Given IV
arm group label: Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)
other name: BMS-936558
other name: CMAB819
other name: MDX-1106
other name: NIVO
other name: Nivolumab Biosimilar CMAB819
other name: ONO-4538
other name: Opdivo
intervention type: Procedure
intervention name: Positron Emission Tomography
description: Undergo PET scan
arm group label: Group A (VSV-IFNbeta-NIS)
arm group label: Group B (VSV-IFNbeta-NIS, ruxolitinib)
arm group label: Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)
other name: Medical Imaging, Positron Emission Tomography
other name: PET
other name: PET Scan
other name: Positron emission tomography (procedure)
other name: Positron Emission Tomography Scan
other name: Positron-Emission Tomography
other name: proton magnetic resonance spectroscopic imaging
other name: PT
intervention type: Biological
intervention name: Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter
description: Given IV
arm group label: Group A (VSV-IFNbeta-NIS)
arm group label: Group B (VSV-IFNbeta-NIS, ruxolitinib)
arm group label: Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)
other name: Oncolytic VSV-hIFNbeta-NIS
other name: Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter
other name: Voyager-V1
other name: VSV-expressing hIFNb and NIS
other name: VSV-hIFNb-NIS
other name: VSV-hIFNbeta-NIS
other name: VV1
intervention type: Procedure
intervention name: Single Photon Emission Computed Tomography
description: Undergo SPECT/CT
arm group label: Group A (VSV-IFNbeta-NIS)
arm group label: Group B (VSV-IFNbeta-NIS, ruxolitinib)
arm group label: Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)
other name: Medical Imaging, Single Photon Emission Computed Tomography
other name: Single Photon Emission Tomography
other name: Single-Photon Emission Computed
other name: single-photon emission computed tomography
other name: SPECT
other name: SPECT imaging
other name: SPECT SCAN
other name: SPET
other name: ST
other name: tomography, emission computed, single photon
other name: Tomography, Emission-Computed, Single-Photon
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martha Q Lacy
role: Principal Investigator
affiliation: Mayo Clinic in Rochester
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
citation: Cook J, Peng KW, Witzig TE, Broski SM, Villasboas JC, Paludo J, Patnaik M, Rajkumar V, Dispenzieri A, Leung N, Buadi F, Bennani N, Ansell SM, Zhang L, Packiriswamy N, Balakrishnan B, Brunton B, Giers M, Ginos B, Dueck AC, Geyer S, Gertz MA, Warsame R, Go RS, Hayman SR, Dingli D, Kumar S, Bergsagel L, Munoz JL, Gonsalves W, Kourelis T, Muchtar E, Kapoor P, Kyle RA, Lin Y, Siddiqui M, Fonder A, Hobbs M, Hwa L, Naik S, Russell SJ, Lacy MQ. Clinical activity of single-dose systemic oncolytic VSV virotherapy in patients with relapsed refractory T-cell lymphoma. Blood Adv. 2022 Jun 14;6(11):3268-3279. doi: 10.1182/bloodadvances.2021006631.
PMID: 35175355
responsible party type: Sponsor
mesh term: Mycoses
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Neoplasms
mesh term: Leukemia, Myeloid
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Leukemia, Myeloid, Acute
mesh term: Lymphoma, Non-Hodgkin
mesh term: Preleukemia
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Mycosis Fungoides
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, T-Cell, Cutaneous
mesh term: Lymphoma, Large-Cell, Anaplastic
mesh term: Myelodysplastic Syndromes
mesh term: Immunoblastic Lymphadenopathy
mesh term: Syndrome
mesh term: Recurrence
mesh term: Iodine
mesh term: Interferons
mesh term: Interferon-beta
mesh term: Cyclophosphamide
mesh term: Nivolumab
mesh term: Ipilimumab