<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/NCT01711684</url>
  </required_header>
  <id_info>
    <org_study_id>JKR-0788</org_study_id>
    <nct_id>NCT01711684</nct_id>
  </id_info>
  <brief_title>Treatment of Cutaneous Metastases With Diphenylcyclopropenone (DPCP)</brief_title>
  <official_title>An Open Label Study Employing the Topical Immunomodulator Diphenylcyclopropenone in a Stabilized Gel to Treat Cutaneous Metastases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rockefeller University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rockefeller University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Melanoma is a life-threatening cancer which poses a significant health burden, especially&#xD;
      when metastatic or spreading to areas other than the original tumor growth. Although various&#xD;
      treatment options are currently available for melanoma, melanomas that have metastasized&#xD;
      widely to the skin pose a significant clinical challenge as the available therapies have&#xD;
      limited effect. This study proposes the use of a topically applied compound named&#xD;
      diphenylcyclopropenone (DPCP) which has been shown to be effective in treating melanoma&#xD;
      patients whose diseases have spread widely throughout the skin. DPCP works by having a&#xD;
      patient's own immune system, which is usually used to fight infections, attack cancerous&#xD;
      cells. This compound has commonly been used to treat other conditions such as warts and hair&#xD;
      loss throughout the world for many years and is known to cause limited side effects. Altering&#xD;
      a patient's own immune system through topical treatments has also been shown to benefit&#xD;
      patients with other cancers that have metastasized to skin such as breast cancer. In this&#xD;
      study, the investigators will use DPCP to treat cutaneous metastases of various cancers&#xD;
      including melanoma. Our overall intention is to get a better understanding of effective&#xD;
      immune responses in the skin that may mediate metastatic cancer regression or cure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label study to determine the efficacy and mechanism(s) of the proprietary&#xD;
      DPCP gel composition as a topical immunotherapeutic agent for the treatment of cutaneous&#xD;
      metastases. This study is investigator initiated, carried out only at Rockefeller University&#xD;
      and the Sponsor holds the IND and is providing the test agent. The products to be evaluated&#xD;
      are 0.4% DPCP, in a non-volatile gel vehicle, and 0.04% DPCP in the same gel vehicle applied&#xD;
      to the target lesions biweekly for 14 weeks. It is our goal to apply the study drug to all&#xD;
      cutaneous metastatic lesions, but at the Investigator's discretion, certain lesions will be&#xD;
      avoided if they are in particularly difficult locations such as around the eyes or on the&#xD;
      lips. The estimated duration of the study is 142 days with 112 days of treatment followed by&#xD;
      subject examination on Day 142. If DPCP is shown to cause resolution of lesions by this&#xD;
      visit, there will be the possibility of continuing DPCP use as long as study medication&#xD;
      continues to be provided to The Rockefeller University.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2012</start_date>
  <completion_date type="Actual">June 22, 2015</completion_date>
  <primary_completion_date type="Actual">June 22, 2015</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>clinically evident inflammatory response elicited by DPCP and the clinically evident efficacy of DPCP to treat cutaneous metastases</measure>
    <time_frame>Day 142</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>histological and gene expression profiling of biopsy specimens</measure>
    <time_frame>Day 142</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Neoplasm Metastasis</condition>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>Diphenylcyclopropenone (DPCP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will have DPCP in a topical gel formulation applied to their cutaneous metastatic lesions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diphenylcyclopropenone (DPCP)</intervention_name>
    <description>Topical application of study drug</description>
    <arm_group_label>Diphenylcyclopropenone (DPCP)</arm_group_label>
    <other_name>Diphencyprone</other_name>
    <other_name>DCP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female at least 18 years of age, up to 99 years of age&#xD;
&#xD;
          -  able to give verbal and written informed consent&#xD;
&#xD;
          -  clinically diagnosed cancer with multiple cutaneous metastases that are able to be&#xD;
             biopsied. The subject may or may not be on concomitant cancer treatments/have internal&#xD;
             metastases.&#xD;
&#xD;
          -  for women of childbearing potential (WOCBP) or in men whose partners may become&#xD;
             pregnant, willingness to use an acceptable method of contraception to prevent&#xD;
             pregnancy for the duration of the study (while receiving study medication and for one&#xD;
             month following the last dose of study medication). Acceptable forms of contraception&#xD;
             are listed in the informed consent form.&#xD;
&#xD;
          -  must have a negative urine pregnancy test (for WOCBP)&#xD;
&#xD;
          -  must be willing and able to have the therapy applied by the investigator, must be&#xD;
             willing and able to self-apply the therapy, and must be willing and able to comply&#xD;
             with study instructions and return for required clinic visits.&#xD;
&#xD;
          -  clinically diagnosed melanoma with multiple cutaneous metastasis that are able to be&#xD;
             biopsied. The subject will be on concurrent PD-1 checkpoint inhibitor therapy&#xD;
             (standard nivolumab or pembrolizumab, not on another clinical trial) and may or may&#xD;
             not have internal metastasis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects taking any of the following systemic or topical therapies within 4 weeks of&#xD;
             enrollment: corticosteroids, immunosuppressants, and/or any other medications that may&#xD;
             affect the outcome of the study&#xD;
&#xD;
          -  subjects who have active localized or systemic medical conditions that, in the opinion&#xD;
             of the investigator, would preclude or make unsafe their participation in the study&#xD;
&#xD;
          -  subjects with any underlying diseases or dermatological conditions of the affected&#xD;
             areas that require the use of interfering topical or systemic therapy&#xD;
&#xD;
          -  subjects who are nursing mothers, pregnant, or planning to become pregnant at anytime&#xD;
             during the course of the study or within 30 days of study completion&#xD;
&#xD;
          -  subjects who are unable to comply with study procedures, communicate effectively,&#xD;
             cooperate with the investigator, or are unable to understand the study&#xD;
&#xD;
          -  history, physical, social, or lab findings suggestive of any medical or psychological&#xD;
             condition that would, in the opinion of the PI, make the candidate ineligible for the&#xD;
             study&#xD;
&#xD;
          -  HIV positive as determined by self-reported history and/or a HIV point-of-care test at&#xD;
             screening&#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>James Krueger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Rockefeller University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Rockefeller University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>November 27, 2017</last_update_submitted>
  <last_update_submitted_qc>November 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rockefeller University</investigator_affiliation>
    <investigator_full_name>Patricia Gilleaudeau</investigator_full_name>
    <investigator_title>Co-Investigator</investigator_title>
  </responsible_party>
  <keyword>Neoplasm Metastasis</keyword>
  <keyword>Melanoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_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/NCT01711684
org study id: JKR-0788
nct id: NCT01711684
lead sponsor: 
has dmc: No
Melanoma is a life-threatening cancer which poses a significant health burden, especially
      when metastatic or spreading to areas other than the original tumor growth. Although various
      treatment options are currently available for melanoma, melanomas that have metastasized
      widely to the skin pose a significant clinical challenge as the available therapies have
      limited effect. This study proposes the use of a topically applied compound named
      diphenylcyclopropenone (DPCP) which has been shown to be effective in treating melanoma
      patients whose diseases have spread widely throughout the skin. DPCP works by having a
      patient's own immune system, which is usually used to fight infections, attack cancerous
      cells. This compound has commonly been used to treat other conditions such as warts and hair
      loss throughout the world for many years and is known to cause limited side effects. Altering
      a patient's own immune system through topical treatments has also been shown to benefit
      patients with other cancers that have metastasized to skin such as breast cancer. In this
      study, the investigators will use DPCP to treat cutaneous metastases of various cancers
      including melanoma. Our overall intention is to get a better understanding of effective
      immune responses in the skin that may mediate metastatic cancer regression or cure.
This is an open label study to determine the efficacy and mechanism(s) of the proprietary
      DPCP gel composition as a topical immunotherapeutic agent for the treatment of cutaneous
      metastases. This study is investigator initiated, carried out only at Rockefeller University
      and the Sponsor holds the IND and is providing the test agent. The products to be evaluated
      are 0.4% DPCP, in a non-volatile gel vehicle, and 0.04% DPCP in the same gel vehicle applied
      to the target lesions biweekly for 14 weeks. It is our goal to apply the study drug to all
      cutaneous metastatic lesions, but at the Investigator's discretion, certain lesions will be
      avoided if they are in particularly difficult locations such as around the eyes or on the
      lips. The estimated duration of the study is 142 days with 112 days of treatment followed by
      subject examination on Day 142. If DPCP is shown to cause resolution of lesions by this
      visit, there will be the possibility of continuing DPCP use as long as study medication
      continues to be provided to The Rockefeller University.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: clinically evident inflammatory response elicited by DPCP and the clinically evident efficacy of DPCP to treat cutaneous metastases
time frame: Day 142
measure: histological and gene expression profiling of biopsy specimens
time frame: Day 142
arm group label: Diphenylcyclopropenone (DPCP)
arm group type: Experimental
description: Subjects will have DPCP in a topical gel formulation applied to their cutaneous metastatic lesions.
intervention type: Drug
intervention name: Diphenylcyclopropenone (DPCP)
description: Topical application of study drug
arm group label: Diphenylcyclopropenone (DPCP)
other name: Diphencyprone
other name: DCP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James Krueger, MD
role: Principal Investigator
affiliation: The Rockefeller University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rockefeller University
investigator full name: Patricia Gilleaudeau
investigator title: Co-Investigator
mesh term: Melanoma
mesh term: Neoplasm Metastasis