<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/NCT03286062</url>
  </required_header>
  <id_info>
    <org_study_id>GYN-105</org_study_id>
    <nct_id>NCT03286062</nct_id>
  </id_info>
  <brief_title>VM110 in Detection of Microscopic Tumors: A Phase I Study</brief_title>
  <official_title>VM110 in Detection of Microscopic Tumors: A Phase I Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fox Chase Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fox Chase Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A laproscopic imaging tecgnology that uses a synthetic agent to detect ovarian and pancreatic&#xD;
      cancers at an early stage so that patients can get treatment early and prevent the disease&#xD;
      from advancing to late stage leading to fatality or recurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current methods of imaging techniques, CT, MRI and PET, fail to detect moderate volume of&#xD;
      diffuse intraperitoneal tumor and provide limited functional information. White light&#xD;
      laproscopy is capable of detecting small volume disease in only half of patients in clinical&#xD;
      remission, missing occult disease in 30% of this patient population. In this study, a&#xD;
      synthetic agent VM110 is to be tested for its ability to detect occult ovarian and pancreatic&#xD;
      cancers. The agent is cleaved by proteases, cathepsin B, L, and S and plasmin in cancer cells&#xD;
      and the fluorescent cleavage product is detected by near infra red imaging probe. High&#xD;
      sensitivity of visualizaion of cancer cells can help detect sub-clinical disease otherwise&#xD;
      unidentifiable by usual methods.&#xD;
&#xD;
      Primary Objectives&#xD;
&#xD;
        1. To investigate the safety and toxicity of escalating doses of VM110 administered IV&#xD;
           prior to laparoscopic surgery.&#xD;
&#xD;
        2. To define the appropriate dose of VM110 for use in future trials.&#xD;
&#xD;
        3. To define the preliminary efficacy: the optimal dose of VM110 in detection of&#xD;
           microscopic peritoneal tumor at laparoscopy not visible with standard white light&#xD;
           laparoscopy. Areas visible with both standard white light and NIRF light, and areas&#xD;
           visible only with NIRF light will be biopsied. Data from pathologic evaluation of these&#xD;
           specimens will be used to determine the efficacy of VM110 with respect to its ability to&#xD;
           detect occult disease not visible with standard white light&#xD;
&#xD;
      Secondary Objectives&#xD;
&#xD;
        1. Estimate sensitivity and specificity of VM110 detection&#xD;
&#xD;
        2. Perform correlative pharmacologic and histopathological analyses&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow accrual&#xD;
  </why_stopped>
  <start_date type="Actual">October 12, 2017</start_date>
  <completion_date type="Actual">April 3, 2020</completion_date>
  <primary_completion_date type="Actual">July 10, 2019</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>
    <intervention_model_description>Multi dose Phase I study with injection of VM110 at 5 dose levels</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency and severity of VM110 related toxicity assessed by NCI CTCAE criteria 4.03</measure>
    <time_frame>3-62 weeks</time_frame>
    <description>Patients would be monitored for severity of adverse events due to VM110 based on NCI CTCAE criteria 4.03</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>VM110</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Escalating dose of agent VM110 given to patients to visualize occult cancer with laproscopic infra red detect</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Agent VM110 and laproscopic infra-red probe</intervention_name>
    <description>Patients with evidence of persistent or recurrent ovarian/ pancreatic cancer would be injected with escalating dose of VM110 24 hr prior to laproscopic surgery to collect biopsy sample in white light and by visualizing the cancerous mass using the laproscopic infra red probe</description>
    <arm_group_label>VM110</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with known or suspected pancreatic or ovarian carcinoma who will be&#xD;
             undergoing clinically appropriate laparoscopic evaluation or treatment. Patients will&#xD;
             not undergo laparoscopy solely for the purpose of participation in this trial.&#xD;
&#xD;
          2. Patients must have evidence of disease either through elevation of tumor markers or&#xD;
             radiologic evidence of disease&#xD;
&#xD;
          3. Patient may be male or female and of any race / ethnicity.&#xD;
&#xD;
          4. Participation in this trial will not significantly alter pre-surgical, surgical or&#xD;
             post-surgical care&#xD;
&#xD;
          5. ECOG PS of 0-1&#xD;
&#xD;
          6. Patients should be free of active infection requiring antibiotics&#xD;
&#xD;
          7. Any therapy directed at the malignant tumor, including immunologic agents, must be&#xD;
             discontinued at least three weeks prior to registration&#xD;
&#xD;
          8. Patients must have adequate:&#xD;
&#xD;
               -  Renal function: serum creatinine less than or equal to 1.5 x institutional upper&#xD;
                  limit normal (ULN)&#xD;
&#xD;
               -  Hepatic function: Total bilirubin less than or equal to 1.5 x ULN , SGOT and&#xD;
                  alkaline phosphatase less than or equal to 2.5 x ULN&#xD;
&#xD;
               -  PTT (partial thromboplastin time) ≤ 1x ULN and INR ≤ 1.5 x ULN.&#xD;
&#xD;
          9. Women of child-bearing potential (WOCBP), defined as all women physiologically capable&#xD;
             of becoming pregnant, must use highly effective methods of contraception during the&#xD;
             study and 8 weeks after. Highly effective contraception methods include combination of&#xD;
             any two of the following:&#xD;
&#xD;
               1. Use of oral, injected or implanted hormonal methods of contraception, or;&#xD;
&#xD;
               2. Placement of an intrauterine device (IUD) or intrauterine system (IUS);&#xD;
&#xD;
               3. Barrier methods of contraception: condom or occlusive cap (diaphragm or&#xD;
                  cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;&#xD;
&#xD;
               4. Total abstinence or;&#xD;
&#xD;
               5. Male/female sterilization&#xD;
&#xD;
         10. Women are considered post-menopausal and not of child-bearing potential if they have&#xD;
             had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile&#xD;
             (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral&#xD;
             oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior&#xD;
             to randomization. In the case of oophorectomy alone, only when the reproductive status&#xD;
             of the woman has been confirmed by follow up hormone level assessment is she&#xD;
             considered not of child-bearing potential.&#xD;
&#xD;
             a. Male patients whose sexual partner(s) are WOCBP who are not willing to use adequate&#xD;
             contraception, during the study and for 8 weeks after the end of treatment&#xD;
&#xD;
         11. Age ≥ 18&#xD;
&#xD;
         12. Capable of complying with study procedures and communicating with study personnel.&#xD;
&#xD;
         13. Patients must have signed an approved informed consent and authorization permitting&#xD;
             release of personal health information. Ability to understand and willingness to sign&#xD;
             a written informed consent and HIPAA consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have received prior radiotherapy to any portion of the abdominal cavity&#xD;
             or pelvis are excluded. Prior radiation for localized cancer of the breast, head and&#xD;
             neck, or skin is permitted, provided that it was completed more than three years prior&#xD;
             to registration, and the patient remains free of recurrent or metastatic disease.&#xD;
&#xD;
          2. Patients with an active bleeding diathesis or on oral anti-vitamin K medication&#xD;
             (except low-dose warfarin used for catheter-related thrombosis prophylaxis).&#xD;
&#xD;
          3. Prior history of hypersensitivity to Pegylated liposomal doxorubicin or ICG allergy.&#xD;
             Caution should be taken if prior ICG allergy is noted.&#xD;
&#xD;
          4. Pregnant or nursing (lactating) women&#xD;
&#xD;
          5. History of congestive cardiac failure or an EKG suggesting significant conduction&#xD;
             defect, or myocardial ischemia, or active psychiatric disease requiring treatment that&#xD;
             would interfere with the understanding or conduct of the study.&#xD;
&#xD;
          6. Subject has previously received VM110, or any other investigational product in the&#xD;
             past thirty days.&#xD;
&#xD;
          7. Inadequate tumor sites or volume to allow for biopsy per standard of care.&#xD;
&#xD;
          8. Patients with psychiatric or other conditions rendering them incapable of&#xD;
             participating in informed consent or the requirements of this protocol or other&#xD;
             condition or personal circumstance that, in the judgment of the investigator, might&#xD;
             interfere with the collection of complete good quality data.&#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>Gina Martina-Smaldone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fox Chase Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111-2497</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>April 3, 2020</last_update_submitted>
  <last_update_submitted_qc>April 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03286062
org study id: GYN-105
nct id: NCT03286062
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
A laproscopic imaging tecgnology that uses a synthetic agent to detect ovarian and pancreatic
      cancers at an early stage so that patients can get treatment early and prevent the disease
      from advancing to late stage leading to fatality or recurrence.
Current methods of imaging techniques, CT, MRI and PET, fail to detect moderate volume of
      diffuse intraperitoneal tumor and provide limited functional information. White light
      laproscopy is capable of detecting small volume disease in only half of patients in clinical
      remission, missing occult disease in 30% of this patient population. In this study, a
      synthetic agent VM110 is to be tested for its ability to detect occult ovarian and pancreatic
      cancers. The agent is cleaved by proteases, cathepsin B, L, and S and plasmin in cancer cells
      and the fluorescent cleavage product is detected by near infra red imaging probe. High
      sensitivity of visualizaion of cancer cells can help detect sub-clinical disease otherwise
      unidentifiable by usual methods.

      Primary Objectives

        1. To investigate the safety and toxicity of escalating doses of VM110 administered IV
           prior to laparoscopic surgery.

        2. To define the appropriate dose of VM110 for use in future trials.

        3. To define the preliminary efficacy: the optimal dose of VM110 in detection of
           microscopic peritoneal tumor at laparoscopy not visible with standard white light
           laparoscopy. Areas visible with both standard white light and NIRF light, and areas
           visible only with NIRF light will be biopsied. Data from pathologic evaluation of these
           specimens will be used to determine the efficacy of VM110 with respect to its ability to
           detect occult disease not visible with standard white light

      Secondary Objectives

        1. Estimate sensitivity and specificity of VM110 detection

        2. Perform correlative pharmacologic and histopathological analyses
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Multi dose Phase I study with injection of VM110 at 5 dose levels
primary purpose: Diagnostic
masking: None (Open Label)
measure: Frequency and severity of VM110 related toxicity assessed by NCI CTCAE criteria 4.03
time frame: 3-62 weeks
description: Patients would be monitored for severity of adverse events due to VM110 based on NCI CTCAE criteria 4.03
arm group label: VM110
arm group type: Experimental
description: Escalating dose of agent VM110 given to patients to visualize occult cancer with laproscopic infra red detect
intervention type: Combination Product
intervention name: Agent VM110 and laproscopic infra-red probe
description: Patients with evidence of persistent or recurrent ovarian/ pancreatic cancer would be injected with escalating dose of VM110 24 hr prior to laproscopic surgery to collect biopsy sample in white light and by visualizing the cancerous mass using the laproscopic infra red probe
arm group label: VM110
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gina Martina-Smaldone, MD
role: Principal Investigator
affiliation: Fox Chase Cancer Center
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No