<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/NCT04469075</url>
  </required_header>
  <id_info>
    <org_study_id>19-342</org_study_id>
    <nct_id>NCT04469075</nct_id>
  </id_info>
  <brief_title>Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields</brief_title>
  <official_title>The PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy With Clindamycin and Triamcinolone in Glioblastoma Patients Treated With Tumor Treating Fields</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <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>
      The participants are being treated with Tumor Treating Fields (TTFields) for malignant&#xD;
      glioma, and this type of treatment may cause skin-related side effects. This study will test&#xD;
      whether using clindamycin and triamcinolone topical lotions can prevent skin-related side&#xD;
      effects of TTFields.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 9, 2020</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
  <phase>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>
    <intervention_model_description>This is a phase 2, multicenter, open-label study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients without grade 2 or higher skin toxicity</measure>
    <time_frame>up to 120 days</time_frame>
    <description>device-related skin adverse events by investigator assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>skin-related quality of life</measure>
    <time_frame>up to 120 days</time_frame>
    <description>using the PRO-CTCAE for rash, ulcer, and pruritus.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">58</enrollment>
  <condition>Glioblastoma</condition>
  <condition>Recurrent Glioblastoma</condition>
  <condition>Skin Toxicity</condition>
  <arm_group>
    <arm_group_label>topical clindamycin and triamcinolone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who are scheduled to receive TTFields therapy for newly diagnosed GBM will be treated with: topical clindamycin (or approved equivalent) 1% and triamcinolone 0.1%. Participating sites may use an alternative equivalent form of clindamycin, such as a gel, with MSK PI approval</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clindamycin Phosphate</intervention_name>
    <description>phosphate 1% solution triamcinolone 0.01% at every array change (or approved equivalent)</description>
    <arm_group_label>topical clindamycin and triamcinolone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone Acetonide</intervention_name>
    <description>triamcinolone acetonide 0.01% lotion triamcinolone 0.01% at every array change</description>
    <arm_group_label>topical clindamycin and triamcinolone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Diagnosis of newly diagnosed or recurrent GBM with plan to initiate treatment with&#xD;
             TTFields with or without systemic therapy, confirmed by the enrolling institution&#xD;
&#xD;
          -  Able to self-administer topical interventions or has available another person who can&#xD;
             apply the topical agents&#xD;
&#xD;
          -  Treatment with TTF should be initiated within 7 days of planned initiation on this&#xD;
             trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known history of allergy to any ingredient of the study agents&#xD;
&#xD;
          -  Preexisting scalp disorders such as psoriasis or dermatitis that, in the opinion of&#xD;
             the investigator, will affect the grading of skin adverse events, confirmed by&#xD;
             enrolling institution.&#xD;
&#xD;
          -  Use of concurrent topical therapy to the scalp for another dermatologic condition&#xD;
&#xD;
          -  Active, uncontrolled infection requiring systemic or oral antibiotic therapy within 14&#xD;
             days of enrollment&#xD;
&#xD;
          -  Use of greater than 4 mg dexamethasone a day within 14 days of enrollment&#xD;
&#xD;
          -  Malignant glioma&#xD;
&#xD;
          -  Pregnant Women&#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>Mario Lacouture, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mario Lacouture, MD</last_name>
    <phone>646-608-2337</phone>
    <email>lacoutum@mskcc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alina Markova, MD</last_name>
    <phone>646-608-2342</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Priya Kumthekar, MD</last_name>
      <email>p-kumthekar@northwestern.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suriya L Jeyapalan, MD, MPH</last_name>
      <phone>617-636-6227</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Milan Anadkat, MD</last_name>
      <phone>314-362-8180</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hackensack Meridian Health</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samuel Goldlust, MD</last_name>
      <phone>551-996-5266</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center Suffolk - Hauppauge (All Protocol Activities)</name>
      <address>
        <city>Hauppauge</city>
        <state>New York</state>
        <zip>11788</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mario Lacouture, MD</last_name>
      <phone>646-608-2337</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mario Lacouture, MD</last_name>
      <phone>646-608-2337</phone>
    </contact>
    <contact_backup>
      <last_name>Alina Markova, MD</last_name>
      <phone>646-608-2342</phone>
    </contact_backup>
    <investigator>
      <last_name>Mario Lacouture, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yehudit Rothman, PA</last_name>
      <phone>513-558-2968</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clindamycin</keyword>
  <keyword>Triamcinolone</keyword>
  <keyword>Skin-Related Side Effects</keyword>
  <keyword>Recurrent</keyword>
  <keyword>19-342</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clindamycin</mesh_term>
    <mesh_term>Clindamycin palmitate</mesh_term>
    <mesh_term>Clindamycin phosphate</mesh_term>
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Triamcinolone hexacetonide</mesh_term>
    <mesh_term>Triamcinolone diacetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
  </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/NCT04469075
org study id: 19-342
nct id: NCT04469075
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The participants are being treated with Tumor Treating Fields (TTFields) for malignant
      glioma, and this type of treatment may cause skin-related side effects. This study will test
      whether using clindamycin and triamcinolone topical lotions can prevent skin-related side
      effects of TTFields.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a phase 2, multicenter, open-label study.
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients without grade 2 or higher skin toxicity
time frame: up to 120 days
description: device-related skin adverse events by investigator assessment.
measure: skin-related quality of life
time frame: up to 120 days
description: using the PRO-CTCAE for rash, ulcer, and pruritus.
arm group label: topical clindamycin and triamcinolone
arm group type: Experimental
description: Patients who are scheduled to receive TTFields therapy for newly diagnosed GBM will be treated with: topical clindamycin (or approved equivalent) 1% and triamcinolone 0.1%. Participating sites may use an alternative equivalent form of clindamycin, such as a gel, with MSK PI approval
intervention type: Drug
intervention name: Clindamycin Phosphate
description: phosphate 1% solution triamcinolone 0.01% at every array change (or approved equivalent)
arm group label: topical clindamycin and triamcinolone
intervention type: Drug
intervention name: Triamcinolone Acetonide
description: triamcinolone acetonide 0.01% lotion triamcinolone 0.01% at every array change
arm group label: topical clindamycin and triamcinolone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mario Lacouture, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Mario Lacouture, MD
phone: 646-608-2337
email: lacoutum@mskcc.org
last name: Alina Markova, MD
phone: 646-608-2342
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Glioblastoma
mesh term: Clindamycin
mesh term: Clindamycin palmitate
mesh term: Clindamycin phosphate
mesh term: Triamcinolone
mesh term: Triamcinolone Acetonide
mesh term: Triamcinolone hexacetonide
mesh term: Triamcinolone diacetate
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.