<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/NCT01714973</url>
  </required_header>
  <id_info>
    <org_study_id>ST-02-12</org_study_id>
    <nct_id>NCT01714973</nct_id>
  </id_info>
  <brief_title>Study of ST266 Versus Saline in Treating Skin Irritation From Radiation</brief_title>
  <official_title>Phase I Randomized, Blinded Safety and Efficacy Trial of Amnion-derived Cellular Cytokine Solution (ACCS) Versus Saline Sprayed on the Breast of Women Undergoing Radiation Therapy for Breast Cancer After Surgical Removal of the Tumor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Noveome Biotherapeutics, formerly Stemnion</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Noveome Biotherapeutics, formerly Stemnion</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the safety and efficacy of ST266 in treating&#xD;
      radiation burns of the skin in patients undergoing treatments for breast cancer and to&#xD;
      compare ST266 treated burns with those treated with saline placebo controls.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events (AEs) and Significant Adverse Events (SAEs)</measure>
    <time_frame>Start of therapy through six week follow-up visit</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skin inflammation</measure>
    <time_frame>start of therapy through six week follow-up visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QOL)scaled responses</measure>
    <time_frame>start of therapy through one year follow-up</time_frame>
    <description>Quality of Life (QOL) will be evaluated using a QOL Assessment (general to breast cancer patients receiving radiation therapy following tumor removal) and a QOL Supplement (specific to subjects receiving trial treatment). Both documents include subsets of questions, each with a different subscale. The assessments include both lifestyle QOL factors (sleep, activity, friends/family, general life enjoyment, etc.) and breast condition (pain, appearance, ect.). This secondary endpoint will focus on the QOL Supplement, comparing breast condition by treatment, noting changes in both the medial and lateral aspects breast including breast texture (thickening and hardness), pain, tenderness, shape, sensitivity, swelling, redness, itching, flaking skin, blistering and fluid leak. The patient will note, for each item, in which side of the breast they are experiencing the negative breast condition or if there is no difference.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cosmesis</measure>
    <time_frame>6 and 12 months post-treatment</time_frame>
    <description>Cosmesis will be evaluated by photography and investigator assessment using the cosmesis form in National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-39, A Randomized Phase III Study of Conventional Whole Breast Irradiation Versus Partial Breast Irradiation for Women with Stage 0, I, or II Breast Cancer. The following factors will be evaluated in the skin: telangiectasia, atrophy, scarring, pigmentation, erythema, fat necrosis, and fibrosis.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Radiation-induced Dermatitis</condition>
  <arm_group>
    <arm_group_label>ST266 intact</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ten (10) patients will be randomized before the first radiation treatment to receive ST266 (4ml) and saline placebo (4ml), one to the medial segment and the other to the lateral segment. The area of the breast will be divided into two, roughly equal parts, medial and lateral. The randomization scheme will be equal in each of two cohorts. The first cohort will receive ST266 and saline placebo applied to intact skin beginning immediately following the first radiation treatment, to continue immediately following each of ten (10) consecutive radiation treatments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ST266 inflamed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ten (10) patients will be randomized before the first radiation treatment to receive ST266 (4ml) and saline placebo (4ml), one to the medial segment and the other to the lateral segment. The area of the breast will be divided into two, roughly equal parts, medial and lateral. The randomization scheme will be equal in each of two cohorts. The second cohort will receive ST266 and saline placebo applied to inflamed skin (after inflammation is first noted) beginning immediately following the radiation treatment, to continue immediately following each of ten (10) consecutive radiation treatments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ST266</intervention_name>
    <description>Patients will receive ST266 spray, to half the breast and saline to the other half (blinded) after each of ten consecutive radiation therapy treatments. ST266 and saline will be sprayed onto the breast to deliver 0.01 ml/cm2.</description>
    <arm_group_label>ST266 inflamed</arm_group_label>
    <arm_group_label>ST266 intact</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A signed IRB - approved Informed Consent;&#xD;
&#xD;
          -  Women 18 - 80 years of age;&#xD;
&#xD;
          -  Biopsy-proven diagnosis of breast cancer with the tumor surgically removed.&#xD;
&#xD;
          -  Whole breast radiation with or without ipsilateral axilla radiation therapy&#xD;
             recommended by her radiation oncologist.&#xD;
&#xD;
          -  If a woman is of child-bearing potential, she and her partner must use an effective&#xD;
             form of birth control.&#xD;
&#xD;
          -  Willing to participate in the clinical study and comply with the requirements of the&#xD;
             trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnormal liver or kidney function studies being greater than 2x the upper limit of&#xD;
             normal.&#xD;
&#xD;
          -  Patients on hemodialysis&#xD;
&#xD;
          -  Psychiatric condition or substance abuse which in the Investigator's opinion may pose&#xD;
             a threat to patient compliance;&#xD;
&#xD;
          -  History of non-compliance with treatment or clinical visit attendance.&#xD;
&#xD;
          -  Participation in an investigational trial within 30 days of study entry.&#xD;
&#xD;
          -  Women who are pregnant or lactating&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Trombetta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Penn Allegheny Health System</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David L Steed, MD</last_name>
    <role>Study Director</role>
    <affiliation>Noveome Biotherapeutics, formerly Stemnion</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>May 9, 2019</last_update_submitted>
  <last_update_submitted_qc>May 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2019</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>Dermatitis</mesh_term>
    <mesh_term>Radiodermatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT01714973
org study id: ST-02-12
nct id: NCT01714973
lead sponsor: 
has dmc: Yes
The objective of this study is to evaluate the safety and efficacy of ST266 in treating
      radiation burns of the skin in patients undergoing treatments for breast cancer and to
      compare ST266 treated burns with those treated with saline placebo controls.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse Events (AEs) and Significant Adverse Events (SAEs)
time frame: Start of therapy through six week follow-up visit
measure: Skin inflammation
time frame: start of therapy through six week follow-up visit
measure: Quality of Life (QOL)scaled responses
time frame: start of therapy through one year follow-up
description: Quality of Life (QOL) will be evaluated using a QOL Assessment (general to breast cancer patients receiving radiation therapy following tumor removal) and a QOL Supplement (specific to subjects receiving trial treatment). Both documents include subsets of questions, each with a different subscale. The assessments include both lifestyle QOL factors (sleep, activity, friends/family, general life enjoyment, etc.) and breast condition (pain, appearance, ect.). This secondary endpoint will focus on the QOL Supplement, comparing breast condition by treatment, noting changes in both the medial and lateral aspects breast including breast texture (thickening and hardness), pain, tenderness, shape, sensitivity, swelling, redness, itching, flaking skin, blistering and fluid leak. The patient will note, for each item, in which side of the breast they are experiencing the negative breast condition or if there is no difference.
measure: Cosmesis
time frame: 6 and 12 months post-treatment
description: Cosmesis will be evaluated by photography and investigator assessment using the cosmesis form in National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-39, A Randomized Phase III Study of Conventional Whole Breast Irradiation Versus Partial Breast Irradiation for Women with Stage 0, I, or II Breast Cancer. The following factors will be evaluated in the skin: telangiectasia, atrophy, scarring, pigmentation, erythema, fat necrosis, and fibrosis.
arm group label: ST266 intact
arm group type: Experimental
description: Ten (10) patients will be randomized before the first radiation treatment to receive ST266 (4ml) and saline placebo (4ml), one to the medial segment and the other to the lateral segment. The area of the breast will be divided into two, roughly equal parts, medial and lateral. The randomization scheme will be equal in each of two cohorts. The first cohort will receive ST266 and saline placebo applied to intact skin beginning immediately following the first radiation treatment, to continue immediately following each of ten (10) consecutive radiation treatments.
arm group label: ST266 inflamed
arm group type: Experimental
description: Ten (10) patients will be randomized before the first radiation treatment to receive ST266 (4ml) and saline placebo (4ml), one to the medial segment and the other to the lateral segment. The area of the breast will be divided into two, roughly equal parts, medial and lateral. The randomization scheme will be equal in each of two cohorts. The second cohort will receive ST266 and saline placebo applied to inflamed skin (after inflammation is first noted) beginning immediately following the radiation treatment, to continue immediately following each of ten (10) consecutive radiation treatments.
intervention type: Biological
intervention name: ST266
description: Patients will receive ST266 spray, to half the breast and saline to the other half (blinded) after each of ten consecutive radiation therapy treatments. ST266 and saline will be sprayed onto the breast to deliver 0.01 ml/cm2.
arm group label: ST266 inflamed
arm group label: ST266 intact
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mark Trombetta, MD
role: Principal Investigator
affiliation: West Penn Allegheny Health System
last name: David L Steed, MD
role: Study Director
affiliation: Noveome Biotherapeutics, formerly Stemnion
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dermatitis
mesh term: Radiodermatitis
sharing ipd: No