<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/NCT01673074</url>
  </required_header>
  <id_info>
    <org_study_id>UPCC 02507</org_study_id>
    <nct_id>NCT01673074</nct_id>
  </id_info>
  <brief_title>HPPH and PDT for Pleural Malignancy</brief_title>
  <official_title>A Phase 1 Trial of Photodynamic Therapy With HPPH in Patients With Pleural Malignancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abramson Cancer Center at Penn Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abramson Cancer Center at Penn Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to determine the maximally tolerated photodynamic&#xD;
      therapy (PDT) dose and drug-light interval of PDT using light and HPPH in patients with&#xD;
      pleural malignancy who have undergone a maximal resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Photodynamic therapy (PDT) is an experimental treatment that uses a drug called a&#xD;
      photosensitizer or photosensitizing agent and light to kill cells. When photosensitizers are&#xD;
      exposed to a specific wavelength of light, they produce a form of oxygen that kills hearby&#xD;
      cells. The appeal o PDT in oncology has been that the photosensitizer is retained in tumor&#xD;
      tissue for longer periods of time compared to normal tissues. This reported differential of&#xD;
      photosensitizer retention in tumor compared to normal tissues provides the potential for an&#xD;
      enhanced therapeutic index minimizing normal tissue toxicity has prompted an interest in&#xD;
      studying PDT as a cancer treatment and is a proposed treatment for a variety of malignancies&#xD;
      and pre-malignant conditions. The proposed study is a Phase I trial of photodynamic therapy&#xD;
      (PDT) for the treatment of patients with pleural malignancies. To participate patients must&#xD;
      be 18 years of age or older, must have a histological diagnosis of pleural malignancy, must&#xD;
      have disease limited to the hemithorax (one side of the chest), must be medically suitable&#xD;
      for resection, and must have a ECOG performance status of 0-2. Patients who have received&#xD;
      prior surgery, gene therapy, or combination chemotherapy will also be permitted if it has&#xD;
      been at least 30 days since the last treatment. Patients will be given HPPH, by intravenous&#xD;
      injection prior to surgery. HPPH is a chlorine based photosensitizer used along with PDT to&#xD;
      prevent recurrence of tumors following surgical removal. After successful tumor removal light&#xD;
      from a tunable dye laser or diode laser will be administered. The starting dose of PDT will&#xD;
      ve administered 24 or 48 hours prior to surgical resection. Red light will be used to&#xD;
      illuminate the entire thoracic cavity. If adequate removal of the tumor cannot be performed ,&#xD;
      the patient will not be eligible to receive light therapy. In parallel laboratory studies,&#xD;
      biopsies of tumor and normal tissues will be taken from the resection specimens. Uptake of&#xD;
      HPPH will be measured in tumor and normal tissues and tumor to normal tissue ratios of HPPH&#xD;
      will be determined. Assessment of molecular signaling including EGFR, Akt, and MAPK will be&#xD;
      made in tumor prior to and after light delivery. Patients will simultaneously be enrolled on&#xD;
      a companion protocol in which the 2-nitroimidazole, EF5 will be administered to determine&#xD;
      tumor oxygen concentration. Finally, non-invasive measurements of optical properties, tissue&#xD;
      oxygenation, photosensitizer uptake, and blood flow will be made intraoperatively. After&#xD;
      hospital discharge patients will be seen routinely in outpatient Thoracic Surgery and&#xD;
      Radiation Oncology Department clinics. These follow visits will occur one month., two months&#xD;
      later and every three months of the first 24 months to assess treatment related toxicities. A&#xD;
      history and physical examination, laboratory and a CT or MRI of the chest will be performed&#xD;
      every 3 months. A follow-up chest x-ray will be obtained as clinically indicated. An&#xD;
      assessment of toxicity will be made at each follow-up visit. After 24 months, follow-up&#xD;
      should be scheduled as clinically indicated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2007</start_date>
  <completion_date type="Actual">October 8, 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <primary_purpose>Treatment</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Adverse Events</measure>
  </primary_outcome>
  <enrollment type="Anticipated">37</enrollment>
  <condition>Pleural Malignancy</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>(PDT) Photodynamic therapy</intervention_name>
    <description>photosensitizer</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a histologic diagnosis of a pleural malignancy who in the opinion of the&#xD;
             attending thoracic surgeon can be resected to a maximal thickness of &lt; 0.5cm. Patients&#xD;
             must have disease limited to the hemithorax. Patients whonhave received prior surgery,&#xD;
             gene therapy, or combination chemotherapy will be permitted if it has been at least 30&#xD;
             days since the last treatment. Patients may receive post-operative chemotherapy or&#xD;
             radiation therapy after completion of surgery and PDT if these treatments are&#xD;
             clinically indicated.&#xD;
&#xD;
          -  ECOG performance status of 0-2.&#xD;
&#xD;
          -  Medical suitability for resection.&#xD;
&#xD;
          -  18 years of age or older.&#xD;
&#xD;
          -  Patients must sign a document that indicates that they are aware of the investigative&#xD;
             nature of the treatment of this protocol and the potential benefits and risks.&#xD;
             Patients unwilling to sign informed consent are excluded from the study.&#xD;
&#xD;
          -  All cell types of pleural malignancy will be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with active co-existing malignancy are excluded.&#xD;
&#xD;
          -  Pregnant or lactating patients.&#xD;
&#xD;
          -  Patients who have a history of HIV disease.&#xD;
&#xD;
          -  Patients who have a white count less than 2500 per cubic mm or platelets less than&#xD;
             100,000/cubic mm.&#xD;
&#xD;
          -  Serum creatinine equal or greater than 2.5 mg/deciliter. Patients who have severe&#xD;
             liver disease including cirrhosis, Grade III-IV elevations in liver function studies,&#xD;
             or bilirubin in excess of 1.5 mg/deciliter.&#xD;
&#xD;
          -  Patients with porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.&#xD;
&#xD;
          -  Patients who have received prior mantle radiation.&#xD;
&#xD;
          -  Patients who have received Alimta&lt;8 weeks prior to surgery.&#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>Keith Cengel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abramson Cancer Center at Penn Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abramson Cancer Center of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>April 7, 2020</last_update_submitted>
  <last_update_submitted_qc>April 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2020</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>Neoplasms</mesh_term>
  </condition_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/NCT01673074
org study id: UPCC 02507
nct id: NCT01673074
lead sponsor: 
has dmc: Yes
The primary objective of the study is to determine the maximally tolerated photodynamic
      therapy (PDT) dose and drug-light interval of PDT using light and HPPH in patients with
      pleural malignancy who have undergone a maximal resection.
Photodynamic therapy (PDT) is an experimental treatment that uses a drug called a
      photosensitizer or photosensitizing agent and light to kill cells. When photosensitizers are
      exposed to a specific wavelength of light, they produce a form of oxygen that kills hearby
      cells. The appeal o PDT in oncology has been that the photosensitizer is retained in tumor
      tissue for longer periods of time compared to normal tissues. This reported differential of
      photosensitizer retention in tumor compared to normal tissues provides the potential for an
      enhanced therapeutic index minimizing normal tissue toxicity has prompted an interest in
      studying PDT as a cancer treatment and is a proposed treatment for a variety of malignancies
      and pre-malignant conditions. The proposed study is a Phase I trial of photodynamic therapy
      (PDT) for the treatment of patients with pleural malignancies. To participate patients must
      be 18 years of age or older, must have a histological diagnosis of pleural malignancy, must
      have disease limited to the hemithorax (one side of the chest), must be medically suitable
      for resection, and must have a ECOG performance status of 0-2. Patients who have received
      prior surgery, gene therapy, or combination chemotherapy will also be permitted if it has
      been at least 30 days since the last treatment. Patients will be given HPPH, by intravenous
      injection prior to surgery. HPPH is a chlorine based photosensitizer used along with PDT to
      prevent recurrence of tumors following surgical removal. After successful tumor removal light
      from a tunable dye laser or diode laser will be administered. The starting dose of PDT will
      ve administered 24 or 48 hours prior to surgical resection. Red light will be used to
      illuminate the entire thoracic cavity. If adequate removal of the tumor cannot be performed ,
      the patient will not be eligible to receive light therapy. In parallel laboratory studies,
      biopsies of tumor and normal tissues will be taken from the resection specimens. Uptake of
      HPPH will be measured in tumor and normal tissues and tumor to normal tissue ratios of HPPH
      will be determined. Assessment of molecular signaling including EGFR, Akt, and MAPK will be
      made in tumor prior to and after light delivery. Patients will simultaneously be enrolled on
      a companion protocol in which the 2-nitroimidazole, EF5 will be administered to determine
      tumor oxygen concentration. Finally, non-invasive measurements of optical properties, tissue
      oxygenation, photosensitizer uptake, and blood flow will be made intraoperatively. After
      hospital discharge patients will be seen routinely in outpatient Thoracic Surgery and
      Radiation Oncology Department clinics. These follow visits will occur one month., two months
      later and every three months of the first 24 months to assess treatment related toxicities. A
      history and physical examination, laboratory and a CT or MRI of the chest will be performed
      every 3 months. A follow-up chest x-ray will be obtained as clinically indicated. An
      assessment of toxicity will be made at each follow-up visit. After 24 months, follow-up
      should be scheduled as clinically indicated.
primary purpose: Treatment
measure: Number of Adverse Events
intervention type: Drug
intervention name: (PDT) Photodynamic therapy
description: photosensitizer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Keith Cengel, MD
role: Principal Investigator
affiliation: Abramson Cancer Center at Penn Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms