<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/NCT03015324</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-16-MULTI-17</org_study_id>
    <nct_id>NCT03015324</nct_id>
  </id_info>
  <brief_title>Biological Effects of Agent on PAR-4 Levels With Resected Solid Tumors</brief_title>
  <official_title>Biological Effects of Maintenance Usage of Hydroxychloroquine on PAR-4 Levels in Patients With Resected Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peng Wang, MD PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kentucky</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hydroxychloroquine will be administered on an outpatient basis within 12 weeks after primary&#xD;
      surgery followed by adjuvant chemotherapy /or radiation therapy (if needed).&#xD;
      Hydroxychloroquine will be administered orally at a dose of 400 mg daily for 90 days.&#xD;
      Subjects will receive HCQ every day.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Actual">February 2, 2021</completion_date>
  <primary_completion_date type="Actual">February 3, 2020</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>PAR-4 increase</measure>
    <time_frame>3 months</time_frame>
    <description>Proportion of patients exhibiting a four-fold increase in PAR-4 levels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete Serological Response</measure>
    <time_frame>12 months</time_frame>
    <description>Rate of complete serological response in prostate cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>12 months</time_frame>
    <description>Progression free survival in other resected solid tumors</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Solid Tumor</condition>
  <arm_group>
    <arm_group_label>Hydroxychloroquine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydroxychloroquine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxychloroquine</intervention_name>
    <description>Hydroxychloroquine</description>
    <arm_group_label>Hydroxychloroquine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed solid tumor that is surgically resected&#xD;
&#xD;
          -  Have completed all planned adjuvant therapy or are not planned for adjuvant therapy&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  ECOG performance status ≤1 (Karnofsky ≥80%)&#xD;
&#xD;
          -  Patients must be able to ingest oral medications (crushing and administering via PEG&#xD;
             tube is acceptable)&#xD;
&#xD;
          -  Patients must have normal organ and marrow function as defined below:&#xD;
&#xD;
          -  absolute neutrophil count ≥1,500/mcL&#xD;
&#xD;
          -  platelets ≥100,000/mcL&#xD;
&#xD;
          -  total bilirubin Less than 1.5 x ULN&#xD;
&#xD;
          -  AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal&#xD;
&#xD;
          -  creatinine within normal institutional limits OR creatinine clearance ≥50 mL/min/1.73&#xD;
             m2 for patients with creatinine levels above institutional normal&#xD;
&#xD;
          -  The effects of hydroxychloroquine on the developing human fetus are unknown. For this&#xD;
             reason, and because anti-malarial agents as well as other therapeutic agents used in&#xD;
             this trial are known to be teratogenic, women of child-bearing potential and men must&#xD;
             agree to use adequate contraception (hormonal or barrier method of birth control;&#xD;
             abstinence) prior to study entry and for the duration of study participation. Should a&#xD;
             woman become pregnant or suspect she is pregnant while she or her partner is&#xD;
             participating in this study, she should inform her treating physician immediately. Men&#xD;
             treated or enrolled on this protocol must also agree to use adequate contraception&#xD;
             prior to the study, for the duration of study participation, and four months after&#xD;
             completion of hydroxychloroquine administration.&#xD;
&#xD;
          -  Men treated or enrolled on this protocol must also agree to use adequate contraception&#xD;
             prior to the study, for the duration of study participation, and four months after&#xD;
             completion of hydroxychloroquine administration.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
          -  Approval for hydroxychloroquine treatment by an eye doctor, based on a screening eye&#xD;
             exam.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with metastatic cancer and/or cancer that is not amenable to surgery.&#xD;
&#xD;
          -  Patients with significant malabsorption as determined by the treating physician.&#xD;
&#xD;
          -  Patients who are receiving any other investigational agents.&#xD;
&#xD;
          -  Patients with known brain metastases are excluded from this clinical trial because of&#xD;
             their poor prognosis and because they often develop progressive neurologic dysfunction&#xD;
             that would confound the evaluation of neurologic and other adverse events. Patients&#xD;
             with primary brain tumors amenable to surgery are allowed on this protocol.&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to hydroxychloroquine or received HCQ in the past six months.&#xD;
&#xD;
          -  Caution should be taken with the use of hydroxychloroquine and any drugs known to&#xD;
             interact with it (Appendix B). Because the lists of these agents are constantly&#xD;
             changing, it is important to regularly consult a frequently updated list such as&#xD;
             http://medicine.iupui.edu/clinpharm/ddis/table.aspx&#xD;
&#xD;
          -  Patients with uncontrolled intercurrent illnesses including, but not limited to,&#xD;
             ongoing or active infection, symptomatic congestive heart failure, unstable angina&#xD;
             pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would&#xD;
             limit compliance with study requirements.&#xD;
&#xD;
          -  Pregnant women are excluded from this study.&#xD;
&#xD;
          -  HIV-positive patients on combination antiretroviral therapy are ineligible&#xD;
&#xD;
          -  Patients that are on enzyme-inducing anti-epileptic medications.&#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>Peng Wang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky Markey Cancer Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 24, 2022</last_update_submitted>
  <last_update_submitted_qc>January 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Peng Wang, MD PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydroxychloroquine</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/NCT03015324
org study id: MCC-16-MULTI-17
nct id: NCT03015324
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Hydroxychloroquine will be administered on an outpatient basis within 12 weeks after primary
      surgery followed by adjuvant chemotherapy /or radiation therapy (if needed).
      Hydroxychloroquine will be administered orally at a dose of 400 mg daily for 90 days.
      Subjects will receive HCQ every day.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PAR-4 increase
time frame: 3 months
description: Proportion of patients exhibiting a four-fold increase in PAR-4 levels
measure: Complete Serological Response
time frame: 12 months
description: Rate of complete serological response in prostate cancer
measure: Progression free survival
time frame: 12 months
description: Progression free survival in other resected solid tumors
arm group label: Hydroxychloroquine
arm group type: Experimental
description: Hydroxychloroquine
intervention type: Drug
intervention name: Hydroxychloroquine
description: Hydroxychloroquine
arm group label: Hydroxychloroquine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peng Wang, MD, PhD
role: Principal Investigator
affiliation: University of Kentucky
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Peng Wang, MD PhD
investigator title: Principal Investigator
mesh term: Neoplasms
mesh term: Hydroxychloroquine