<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/NCT03281811</url>
  </required_header>
  <id_info>
    <org_study_id>MC168B</org_study_id>
    <secondary_id>NCI-2017-01649</secondary_id>
    <secondary_id>MC168B</secondary_id>
    <nct_id>NCT03281811</nct_id>
  </id_info>
  <brief_title>Photodynamic Therapy in Treating Patients With Refractory Mycosis Fungoides</brief_title>
  <official_title>A Pilot Study of Photodynamic Therapy in Refractory Plaques and Tumors of Mycosis Fungoides</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot phase II trial studies how well photodynamic therapy works in treating patients&#xD;
      with mycosis fungoides that does not respond to treatment. Photodynamic therapy uses a drug,&#xD;
      such as aminolevulinic acid hydrochloride, that becomes active when it is exposed to light.&#xD;
      The activated drug may kill cancer cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the efficacy of photodynamic therapy (PDT) in refractory tumors and plaques&#xD;
      of mycosis fungoides (MF).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the effects of sequential PDT and radiation therapy (RT). II. To determine&#xD;
      the side effect profile of PDT in MF.&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To determine the quality of life during and after treatment.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy&#xD;
      on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease&#xD;
      progression or unacceptable toxicity. Beginning at week 24, patients undergo radiation&#xD;
      therapy daily for 4 weeks.&#xD;
&#xD;
      After completion of study treatment, patients are followed up for up to 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2017</start_date>
  <completion_date type="Actual">August 12, 2020</completion_date>
  <primary_completion_date type="Actual">February 25, 2020</primary_completion_date>
  <phase>Early 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>Complete clinical response</measure>
    <time_frame>At 24 weeks</time_frame>
    <description>Will be determined by Composite Assessment of Index Lesion Severity (CAILS) and Physician Global Assessment (PGA).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in CAILS score</measure>
    <time_frame>Baseline up to week 24</time_frame>
    <description>Will be conducted and summarized using means, standard deviations and 95% confidence intervals. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher?s exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in field of treatment</measure>
    <time_frame>Baseline up to week 24</time_frame>
    <description>Will be conducted and summarized using means, standard deviations and 95% confidence intervals. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher?s exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Skindex-16 score</measure>
    <time_frame>Baseline up to week 24</time_frame>
    <description>Will be conducted and summarized using means, standard deviations and 95% confidence intervals. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher?s exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AEs)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. AE incidence and severity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient-reported outcomes</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Patient-reported symptoms will be described at each time point using the mean, confidence interval, median, and range. Graphical procedures will include stream plots of individual patient scores and plots of average values over time. Correlational analyses will be done to determine the relationships among patients-reported symptoms, as well as with clinical outcomes (response) and clinician-assessed symptoms (National Cancer Institute [NCI] CTCAE v4).</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life (QOL)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Patient-reported symptoms and QOL will be described at each time point using the mean, confidence interval, median, and range. Graphical procedures will include stream plots of individual patient scores and plots of average values over time. Correlational analyses will be done to determine the relationships among patients-reported symptoms and QOL, as well as with clinical outcomes (response) and clinician-assessed symptoms (NCI CTCAE v4).</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Refractory Mycosis Fungoides</condition>
  <arm_group>
    <arm_group_label>Treatment (aminolevulinic acid hydrochloride, PDT, RT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning at week 24, patients undergo radiation therapy daily for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aminolevulinic Acid Hydrochloride</intervention_name>
    <description>Given topically</description>
    <arm_group_label>Treatment (aminolevulinic acid hydrochloride, PDT, RT)</arm_group_label>
    <other_name>.delta.-Aminolevulinic acid hydrochloride</other_name>
    <other_name>Alacare</other_name>
    <other_name>Ameluz</other_name>
    <other_name>Aminolevulinic Acid HCl</other_name>
    <other_name>Delta-Aminolevulinic Acid HCl</other_name>
    <other_name>Delta-Aminolevulinic Acid Hydrochloride</other_name>
    <other_name>Levulan</other_name>
    <other_name>Levulan Kerastick</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Photodynamic Therapy</intervention_name>
    <description>Undergo PDT</description>
    <arm_group_label>Treatment (aminolevulinic acid hydrochloride, PDT, RT)</arm_group_label>
    <other_name>PDT</other_name>
    <other_name>Photoradiation Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Treatment (aminolevulinic acid hydrochloride, PDT, RT)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation Therapy</intervention_name>
    <description>Undergo RT</description>
    <arm_group_label>Treatment (aminolevulinic acid hydrochloride, PDT, RT)</arm_group_label>
    <other_name>Cancer Radiotherapy</other_name>
    <other_name>Irradiate</other_name>
    <other_name>Irradiated</other_name>
    <other_name>irradiation</other_name>
    <other_name>Radiation</other_name>
    <other_name>Radiotherapeutics</other_name>
    <other_name>Radiotherapy</other_name>
    <other_name>RT</other_name>
    <other_name>Therapy, Radiation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological confirmation of mycosis fungoides as confirmed by the Mayo Clinic Arizona&#xD;
             Dermatopathology Department&#xD;
&#xD;
          -  Patients must have a tumor or plaque that is refractory to conventional treatment&#xD;
             including but not limited to one of the following (up to 4 lesions in a single field&#xD;
             of PDT or RT will be considered for treatment):&#xD;
&#xD;
               -  Plaque stage disease that has failed at least 2 skin directed therapies&#xD;
                  (including topical steroids) or refractory plaques despite at least one systemic&#xD;
                  therapy or plaques with evidence of folliculotropism&#xD;
&#xD;
               -  The presence of a tumor of MF&#xD;
&#xD;
          -  Negative urine pregnancy test done =&lt; 7 days prior to registration, for women of&#xD;
             childbearing potential only&#xD;
&#xD;
          -  Ability to complete questionnaire(s) by themselves or with assistance&#xD;
&#xD;
          -  Provide written informed consent&#xD;
&#xD;
          -  Willing to return to enrolling institution for follow-up (during the Active Monitoring&#xD;
             Phase of the study)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior radiation to the same site deemed to be too high of level of radiation for&#xD;
             retreatment&#xD;
&#xD;
          -  Photosensitivity disorder, including but not limited to porphyria, or concomitant&#xD;
             photosensitizing drugs that place the patient at an elevated risk of developing severe&#xD;
             side effects to PDT or RT&#xD;
&#xD;
          -  Skin cancer other than actinic keratosis, basal cell carcinoma, and squamous cell&#xD;
             carcinoma in situ in the field of RT&#xD;
&#xD;
          -  Active infection at the site to be irradiated&#xD;
&#xD;
          -  Any underlying condition which prevents the patient from being able to undergo the&#xD;
             required number of sessions of PDT or RT and required follow up&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Lactation and a radiation field which would include the breast or nipple or deemed to&#xD;
             place the mother or child at elevated risk of radiation exposure (evaluated by MRP,&#xD;
             ARM, WR, WW)&#xD;
&#xD;
          -  An allergy to a component of Levulan&#xD;
&#xD;
          -  Women of childbearing potential (post-menopausal or not of child-bearing potential) is&#xD;
             defined by: 1 year of natural (spontaneous) amenorrhea or surgical bilateral&#xD;
             oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at&#xD;
             least 6 weeks ago; oophorectomy alone must confirmed by follow up hormone level&#xD;
             assessment to be considered not of child-bearing potential, defined as all women&#xD;
             physiologically capable of becoming pregnant, unless they are using basic methods of&#xD;
             contraception which includes:&#xD;
&#xD;
               -  Total abstinence (Periodic abstinence and withdrawal are not acceptable methods&#xD;
                  of contraception)&#xD;
&#xD;
               -  Female sterilization (bilateral oophorectomy with or without hysterectomy), total&#xD;
                  hysterectomy, or tubal ligation at least 6 weeks before taking study treatment;&#xD;
                  oophorectomy alone requires follow up hormone level assessment for fertility&#xD;
&#xD;
               -  Male sterilization (at least 6 months prior to screening); the vasectomized male&#xD;
                  partner should be the sole partner for that subject&#xD;
&#xD;
               -  Barrier methods of contraception: condom or occlusive cap&#xD;
&#xD;
               -  Use of oral, injected or implanted hormonal methods of contraception or other&#xD;
                  forms or hormonal contraception that have complete efficacy (failure &lt; 1%); (the&#xD;
                  dose of the contraceptive should be stable for 3 months)&#xD;
&#xD;
          -  Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment&#xD;
             of the investigator, would make the patient inappropriate for entry into this study or&#xD;
             interfere significantly with the proper assessment of safety and toxicity of the&#xD;
             prescribed regimens&#xD;
&#xD;
          -  Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)&#xD;
             positive and currently receiving antiretroviral therapy; NOTE: Patients known to be&#xD;
             HIV positive, but without clinical evidence of an immunocompromised state, are&#xD;
             eligible for this trial&#xD;
&#xD;
          -  Uncontrolled inter-current illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#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>Aaron Mangold</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2023</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>Aminolevulinic Acid</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/NCT03281811
org study id: MC168B
secondary id: NCI-2017-01649
secondary id: MC168B
nct id: NCT03281811
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This pilot phase II trial studies how well photodynamic therapy works in treating patients
      with mycosis fungoides that does not respond to treatment. Photodynamic therapy uses a drug,
      such as aminolevulinic acid hydrochloride, that becomes active when it is exposed to light.
      The activated drug may kill cancer cells.
PRIMARY OBJECTIVES:

      I. To determine the efficacy of photodynamic therapy (PDT) in refractory tumors and plaques
      of mycosis fungoides (MF).

      SECONDARY OBJECTIVES:

      I. To determine the effects of sequential PDT and radiation therapy (RT). II. To determine
      the side effect profile of PDT in MF.

      EXPLORATORY OBJECTIVES:

      I. To determine the quality of life during and after treatment.

      OUTLINE:

      Patients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy
      on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease
      progression or unacceptable toxicity. Beginning at week 24, patients undergo radiation
      therapy daily for 4 weeks.

      After completion of study treatment, patients are followed up for up to 8 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete clinical response
time frame: At 24 weeks
description: Will be determined by Composite Assessment of Index Lesion Severity (CAILS) and Physician Global Assessment (PGA).
measure: Change in CAILS score
time frame: Baseline up to week 24
description: Will be conducted and summarized using means, standard deviations and 95% confidence intervals. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher?s exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.
measure: Change in field of treatment
time frame: Baseline up to week 24
description: Will be conducted and summarized using means, standard deviations and 95% confidence intervals. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher?s exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.
measure: Change in Skindex-16 score
time frame: Baseline up to week 24
description: Will be conducted and summarized using means, standard deviations and 95% confidence intervals. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher?s exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.
measure: Incidence of adverse events (AEs)
time frame: Up to 2 years
description: The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. AE incidence and severity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0.
measure: Patient-reported outcomes
time frame: Up to 2 years
description: Patient-reported symptoms will be described at each time point using the mean, confidence interval, median, and range. Graphical procedures will include stream plots of individual patient scores and plots of average values over time. Correlational analyses will be done to determine the relationships among patients-reported symptoms, as well as with clinical outcomes (response) and clinician-assessed symptoms (National Cancer Institute [NCI] CTCAE v4).
measure: Quality of life (QOL)
time frame: Up to 2 years
description: Patient-reported symptoms and QOL will be described at each time point using the mean, confidence interval, median, and range. Graphical procedures will include stream plots of individual patient scores and plots of average values over time. Correlational analyses will be done to determine the relationships among patients-reported symptoms and QOL, as well as with clinical outcomes (response) and clinician-assessed symptoms (NCI CTCAE v4).
arm group label: Treatment (aminolevulinic acid hydrochloride, PDT, RT)
arm group type: Experimental
description: Patients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning at week 24, patients undergo radiation therapy daily for 4 weeks.
intervention type: Drug
intervention name: Aminolevulinic Acid Hydrochloride
description: Given topically
arm group label: Treatment (aminolevulinic acid hydrochloride, PDT, RT)
other name: .delta.-Aminolevulinic acid hydrochloride
other name: Alacare
other name: Ameluz
other name: Aminolevulinic Acid HCl
other name: Delta-Aminolevulinic Acid HCl
other name: Delta-Aminolevulinic Acid Hydrochloride
other name: Levulan
other name: Levulan Kerastick
intervention type: Drug
intervention name: Photodynamic Therapy
description: Undergo PDT
arm group label: Treatment (aminolevulinic acid hydrochloride, PDT, RT)
other name: PDT
other name: Photoradiation Therapy
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Treatment (aminolevulinic acid hydrochloride, PDT, RT)
other name: Quality of Life Assessment
intervention type: Radiation
intervention name: Radiation Therapy
description: Undergo RT
arm group label: Treatment (aminolevulinic acid hydrochloride, PDT, RT)
other name: Cancer Radiotherapy
other name: Irradiate
other name: Irradiated
other name: irradiation
other name: Radiation
other name: Radiotherapeutics
other name: Radiotherapy
other name: RT
other name: Therapy, Radiation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aaron Mangold
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Sponsor
mesh term: Mycoses
mesh term: Mycosis Fungoides
mesh term: Aminolevulinic Acid