<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/NCT03288818</url>
  </required_header>
  <id_info>
    <org_study_id>16C.514</org_study_id>
    <nct_id>NCT03288818</nct_id>
  </id_info>
  <brief_title>Low Dose Total Skin Electron Beam Radiation Therapy and Mechlorethamine Hydrochloride Gel in Treating Patients With Mycosis Fungoides</brief_title>
  <official_title>IIS: Phase II Study of Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Cancer Center at Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Actelion</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Thomas Jefferson University</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies how well low dose total skin electron beam radiation therapy and&#xD;
      mechlorethamine hydrochloride gel work in treating patients with mycosis fungoides. Total&#xD;
      skin electron beam radiation therapy uses high energy x-rays directed at the entire surface&#xD;
      of the body to kill cancer cells and shrink tumors. Mechlorethamine hydrochloride gel may&#xD;
      help patients in remission of disease, reduction in disease staging, and enhanced quality of&#xD;
      life. Giving total skin electron beam radiation therapy and mechlorethamine hydrochloride gel&#xD;
      may work better in treating patients with mycosis fungoides.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the time to progression of patients treated with total skin electron beam&#xD;
      therapy (TSEBT) followed by the year-long maintenance mechlorethamine hydrochloride gel&#xD;
      (Valchlor) regimen.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the response rate (complete response [CR] and partial response [PR]) of patients&#xD;
      treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance&#xD;
      Valchlor regimen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding discontinued&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 2018</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to progression</measure>
    <time_frame>Up to week 54</time_frame>
    <description>Will be evaluated using the Kaplan-Meier estimator of the survival curves.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Mycosis Fungoides</condition>
  <arm_group>
    <arm_group_label>low dose TSEBT, mechlorethamine hydrochloride gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo low dose TSEBT for 2 weeks. After 30 days of observation, patients receive mechlorethamine hydrochloride gel topically daily at week 7 and then once weekly up to week 54.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mechlorethamine Hydrochloride Gel</intervention_name>
    <description>Given topically</description>
    <arm_group_label>low dose TSEBT, mechlorethamine hydrochloride gel</arm_group_label>
    <other_name>Valchlor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total Skin Electron Beam Radiation Therapy</intervention_name>
    <description>Undergo low dose (TSEBT) Total Skin Electron Beam Therapy</description>
    <arm_group_label>low dose TSEBT, mechlorethamine hydrochloride gel</arm_group_label>
    <other_name>TSEB radiation therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documentation of diagnosis as evidenced by one or more clinical features consistent&#xD;
             with mycosis fungoides cutaneous T-cell lymphoma&#xD;
&#xD;
          -  Written informed consent obtained from subject or subject's legal representative and&#xD;
             ability for subject to comply with requirements of the study&#xD;
&#xD;
          -  Skin biopsy specimen of representative lesion obtained at screening of study and&#xD;
             deemed diagnostic of mycosis fungoides by principal investigator&#xD;
&#xD;
          -  Mycosis fungoides patients that have stage T2-4 N0-1 M0B0 disease&#xD;
&#xD;
          -  Availability of subject to be observed for up to 18 months post-screening evaluation&#xD;
&#xD;
          -  Life expectancy greater than 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding females&#xD;
&#xD;
          -  Presence of a condition or abnormality that in the opinion of the investigator would&#xD;
             compromise the safety of the patient or the quality of the data&#xD;
&#xD;
          -  Patients diagnosed with Sezary syndrome; Sezary syndrome is equivalent to mycosis&#xD;
             fungoides that develops to stage IVA/B with B2 (high blood tumor burden) involvement,&#xD;
             and as such requires a more aggressive treatment regimen than Valchlor or TSEBT&#xD;
&#xD;
          -  Underlying medical condition including unstable cardiac disease, or other serious&#xD;
             illness that would impair the ability of the patient to undergo treatment&#xD;
&#xD;
          -  Minimum 3 weeks since prior systematic treatment or phototherapy&#xD;
&#xD;
          -  Exclusion of people that do not understand the risks, such as decisionally-impaired&#xD;
             individuals, prisoners, and vulnerable populations&#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>Joya Sahu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sidney Kimmel Cancer Center at Thomas Jefferson University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sidney Kimmel Cancer Center at Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://hospitals.jefferson.edu/</url>
    <description>Thomas Jefferson University Hospital</description>
  </link>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>January 25, 2018</last_update_submitted>
  <last_update_submitted_qc>January 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycoses</mesh_term>
    <mesh_term>Mycosis Fungoides</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mechlorethamine</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/NCT03288818
org study id: 16C.514
nct id: NCT03288818
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This phase II trial studies how well low dose total skin electron beam radiation therapy and
      mechlorethamine hydrochloride gel work in treating patients with mycosis fungoides. Total
      skin electron beam radiation therapy uses high energy x-rays directed at the entire surface
      of the body to kill cancer cells and shrink tumors. Mechlorethamine hydrochloride gel may
      help patients in remission of disease, reduction in disease staging, and enhanced quality of
      life. Giving total skin electron beam radiation therapy and mechlorethamine hydrochloride gel
      may work better in treating patients with mycosis fungoides.
PRIMARY OBJECTIVES:

      I. To assess the time to progression of patients treated with total skin electron beam
      therapy (TSEBT) followed by the year-long maintenance mechlorethamine hydrochloride gel
      (Valchlor) regimen.

      SECONDARY OBJECTIVES:

      I. To assess the response rate (complete response [CR] and partial response [PR]) of patients
      treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance
      Valchlor regimen.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to progression
time frame: Up to week 54
description: Will be evaluated using the Kaplan-Meier estimator of the survival curves.
arm group label: low dose TSEBT, mechlorethamine hydrochloride gel
arm group type: Experimental
description: Patients undergo low dose TSEBT for 2 weeks. After 30 days of observation, patients receive mechlorethamine hydrochloride gel topically daily at week 7 and then once weekly up to week 54.
intervention type: Drug
intervention name: Mechlorethamine Hydrochloride Gel
description: Given topically
arm group label: low dose TSEBT, mechlorethamine hydrochloride gel
other name: Valchlor
intervention type: Procedure
intervention name: Total Skin Electron Beam Radiation Therapy
description: Undergo low dose (TSEBT) Total Skin Electron Beam Therapy
arm group label: low dose TSEBT, mechlorethamine hydrochloride gel
other name: TSEB radiation therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joya Sahu, MD
role: Principal Investigator
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
facility: 
country: United States
url: http://hospitals.jefferson.edu/
description: Thomas Jefferson University Hospital
responsible party type: Sponsor
mesh term: Mycoses
mesh term: Mycosis Fungoides
mesh term: Mechlorethamine