<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/NCT02219893</url>
  </required_header>
  <id_info>
    <org_study_id>ImmunoPeCa Trial</org_study_id>
    <nct_id>NCT02219893</nct_id>
  </id_info>
  <brief_title>Immunotoxin in Peritoneal Carcinomatosis- ImmunoPeCa Trial</brief_title>
  <acronym>ImmunoPeCa</acronym>
  <official_title>Phase I/II Trial of MOC31PE Immunotoxin in Peritoneal Carcinomatosis From Colorectal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is through a phase I/II clinical trial to assess the safety and&#xD;
      toxicity of intraperitoneally administered MOC31PE immunotoxin, given on the 1.postoperative&#xD;
      day after cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)&#xD;
      for peritoneal metastases from colorectal cancer (CRC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MOC31PE is an immunotoxin that has previously been evaluated in a phase I clinical study&#xD;
      involving patients with advanced EpCAM positive carcinoma to assess the safety and&#xD;
      tolerability profile and the pharmacokinetic behavior of the compound. In this study, the&#xD;
      compound was administered intravenously and was well tolerated. MOC31PE will now be evaluated&#xD;
      on the same parameters in a new phase I/II clinical trial, where the drug will be&#xD;
      administered intraperitoneally to patients with peritoneal metastases from EpCAM positive&#xD;
      colorectal carcinomas.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 10, 2016</completion_date>
  <primary_completion_date type="Actual">December 10, 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Number of Participants with Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>5 years or until disease progression</time_frame>
    <description>Follow-up: 5 years from administration of study drug, or until disease progression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax, Tmax</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measurements will be done at 0, 3, 6, 12, 24, 48 and 72 hours after administration of study drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neutralizing anti-immunotoxin antibody response</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measurements of neutralizing anti-immunotoxin antibody response will be done at 4 and 8 weeks after administration of study drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of disease recurrence</measure>
    <time_frame>5 years or until disease progression</time_frame>
    <description>Serum samples for identification of biomarkers of disease recurrence will be taken at every follow-up for 5 years or until disease progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>Overall survival of all patients will be assessed after 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>5 years</time_frame>
    <description>Follow up period of 5 years, or until disease progression</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <arm_group>
    <arm_group_label>MOC31PE Immunotoxin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug to be instilled on day 1 after cytoreductive surgery and HIPEC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MOC31PE Immunotoxin</intervention_name>
    <description>Patients who meet inclusion criteria will be treated with a single intraperitoneal MOC31PE immunotoxin instillation for 6 hours on the first day after CRS and HIPEC</description>
    <arm_group_label>MOC31PE Immunotoxin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Histologically verified EpCAM positive colorectal cancer&#xD;
&#xD;
          -  Ambulatory with Eastern Cooperative Oncology Group (ECOG) performance status 0-1 at&#xD;
             the time of surgery&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Suspected isolated peritoneal carcinomatosis upon radiologic work-up&#xD;
&#xD;
          -  Complete cytoreduction at surgery and mitomycin C given as standard HIPEC procedure&#xD;
&#xD;
          -  Peritoneal Cancer Index (PCI) ≤ 20&#xD;
&#xD;
          -  Laboratory values at inclusion:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) &gt; 1.5 x 10^9/L&#xD;
&#xD;
               -  Platelets &gt; 100 x 10^9/L&#xD;
&#xD;
               -  Hb &gt; 9g/dL&#xD;
&#xD;
               -  Creatinine ≤ 2x upper limit of normal&#xD;
&#xD;
               -  Bilirubin &lt; 2.0x the upper limit of normal&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2. 5x the&#xD;
                  upper limit of normal&#xD;
&#xD;
               -  Albumin levels &gt; 30 g/L&#xD;
&#xD;
               -  International normalised ratio (INR) &lt;1.3&#xD;
&#xD;
          -  Signed informed consent and expected cooperation with respect to treatment and&#xD;
             follow-up must be obtained and documented according to International Conference of&#xD;
             Harmonisation- Good clinical Practice (ICH GCP), and national/local regulations.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Other synchronous metastatic lesions. Patients may be included if they have had&#xD;
             curative resection of metastatic CRC disease more than 2 years prior to inclusion and&#xD;
             have no relapse at this location is detected.&#xD;
&#xD;
          -  History of prior other malignant disease the last 3 years, except for adequately&#xD;
             treated carcinoma of the cervix or basal or squamous cell skin cancer.&#xD;
&#xD;
          -  History of central nervous system (CNS)- or bone metastases&#xD;
&#xD;
          -  Significant cardiac or other medical illness that would limit activity or survival,&#xD;
             such as severe congestive heart failure, unstable angina, or serious cardiac&#xD;
             arrhythmia&#xD;
&#xD;
          -  History of any liver disease including Hepatitis B or C infection&#xD;
&#xD;
          -  Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start&#xD;
             of treatment&#xD;
&#xD;
          -  BMI &gt; 35&#xD;
&#xD;
          -  Pregnant or breast-feeding patients&#xD;
&#xD;
          -  Alcohol or drug abuse&#xD;
&#xD;
          -  Use of drugs that can influence hepatic function (e.g. phenytoin or phenobarbital)&#xD;
&#xD;
          -  Use of anticoagulants&#xD;
&#xD;
          -  Any reason why, in the opinion of the investigator, the patient should not participate&#xD;
             in the study protocol&#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>Kjersti Flatmark, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Svein Dueland, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo University Hospital- The Norwegian Radium Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>May 24, 2017</last_update_submitted>
  <last_update_submitted_qc>May 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Svein Dueland</investigator_full_name>
    <investigator_title>Senior consultant medical oncology</investigator_title>
  </responsible_party>
  <keyword>Peritoneal Carcinomatosis</keyword>
  <keyword>Peritoneal Metastasis</keyword>
  <keyword>Colorectal Cancer</keyword>
  <keyword>Cytoreductive surgery</keyword>
  <keyword>HIPEC</keyword>
  <keyword>Intraperitoneal treatment</keyword>
  <keyword>Immunotoxin</keyword>
  <keyword>MOC31PE</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Peritoneal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunotoxins</mesh_term>
    <mesh_term>MOC31PE immunotoxin</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/NCT02219893
org study id: ImmunoPeCa Trial
nct id: NCT02219893
lead sponsor: 
has dmc: Yes
The purpose of this study is through a phase I/II clinical trial to assess the safety and
      toxicity of intraperitoneally administered MOC31PE immunotoxin, given on the 1.postoperative
      day after cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
      for peritoneal metastases from colorectal cancer (CRC).
MOC31PE is an immunotoxin that has previously been evaluated in a phase I clinical study
      involving patients with advanced EpCAM positive carcinoma to assess the safety and
      tolerability profile and the pharmacokinetic behavior of the compound. In this study, the
      compound was administered intravenously and was well tolerated. MOC31PE will now be evaluated
      on the same parameters in a new phase I/II clinical trial, where the drug will be
      administered intraperitoneally to patients with peritoneal metastases from EpCAM positive
      colorectal carcinomas.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: 5 years or until disease progression
description: Follow-up: 5 years from administration of study drug, or until disease progression
measure: Cmax, Tmax
time frame: 8 weeks
description: Measurements will be done at 0, 3, 6, 12, 24, 48 and 72 hours after administration of study drug
measure: Neutralizing anti-immunotoxin antibody response
time frame: 8 weeks
description: Measurements of neutralizing anti-immunotoxin antibody response will be done at 4 and 8 weeks after administration of study drug
measure: Biomarkers of disease recurrence
time frame: 5 years or until disease progression
description: Serum samples for identification of biomarkers of disease recurrence will be taken at every follow-up for 5 years or until disease progression
measure: Overall survival
time frame: 5 years
description: Overall survival of all patients will be assessed after 5 years
measure: Disease free survival
time frame: 5 years
description: Follow up period of 5 years, or until disease progression
arm group label: MOC31PE Immunotoxin
arm group type: Experimental
description: Drug to be instilled on day 1 after cytoreductive surgery and HIPEC.
intervention type: Drug
intervention name: MOC31PE Immunotoxin
description: Patients who meet inclusion criteria will be treated with a single intraperitoneal MOC31PE immunotoxin instillation for 6 hours on the first day after CRS and HIPEC
arm group label: MOC31PE Immunotoxin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kjersti Flatmark, MD PhD
role: Principal Investigator
affiliation: Oslo University Hospital
last name: Svein Dueland, MD PhD
role: Principal Investigator
affiliation: Oslo University Hospital
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Svein Dueland
investigator title: Senior consultant medical oncology
mesh term: Colorectal Neoplasms
mesh term: Carcinoma
mesh term: Peritoneal Neoplasms
mesh term: Immunotoxins
mesh term: MOC31PE immunotoxin