<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/NCT01668823</url>
  </required_header>
  <id_info>
    <org_study_id>I 05903</org_study_id>
    <secondary_id>NCI-2010-02114</secondary_id>
    <nct_id>NCT01668823</nct_id>
  </id_info>
  <brief_title>Photodynamic Therapy in Treating Patients With Lung Cancer</brief_title>
  <official_title>A Phase I Study of Light Dose for Photodynamic Therapy(PDT) Using 2-[ 1-hexyloxyethel]-2-devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-small Cell Carcinoma in Situ or Non-small Cell Microinvasive Carcinoma. A Dose Ranging Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Roswell Park Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I trial is studying the side effects and best dose of photodynamic therapy using&#xD;
      HPPH in treating patients with lung cancer. Photodynamic therapy uses a drug, such as HPPH,&#xD;
      that becomes active when it is exposed to a certain kind of light. When the drug is active,&#xD;
      cancer cells are killed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine maximally tolerated light dose (MTID). Identify systemic and normal tissue&#xD;
      toxicity using 2-[hexyloxyethyl)-2-devinyl pyropheophorbide-a (HPPH) for photodynamic therapy&#xD;
      in patients with bronchogenic carcinoma-in-situ (CIS) or microinvasive carcinoma.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To study tumor response in patients with bronchogenic carcinoma-in-situ (CIS) or&#xD;
      bronchogenic microinvasive carcinoma.&#xD;
&#xD;
      OUTLINE: This is a dose-escalation study.&#xD;
&#xD;
      Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients then photodynamic&#xD;
      therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for&#xD;
      endoscopic debridement on day 5.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 4-6 weeks, 6 months, and&#xD;
      then periodically for at least 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2004</start_date>
  <completion_date>June 2014</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>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>MTID</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Defined as the dose at which =&lt; 1 out of 6 patients experiences dose-limiting toxicity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systemic toxicity according to NCI Common Toxicity Criteria version 2</measure>
    <time_frame>Up to 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PDT-related normal tissue toxicity</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Assessed by a scale with grades 0-3 being acceptable, grade 4 being unacceptable, and grade 5 being stopping study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective tumor response</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Adenocarcinoma of the Lung</condition>
  <condition>Large Cell Lung Cancer</condition>
  <condition>Recurrent Non-small Cell Lung Cancer</condition>
  <condition>Squamous Cell Lung Cancer</condition>
  <condition>Stage 0 Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment (PDT using HPPH)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive HPPH IV over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HPPH</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (PDT using HPPH)</arm_group_label>
    <other_name>Photochlor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>photodynamic therapy</intervention_name>
    <description>Undergo photodynamic therapy with HPPH</description>
    <arm_group_label>Treatment (PDT using HPPH)</arm_group_label>
    <other_name>Light Infusion Therapy™</other_name>
    <other_name>PDT</other_name>
    <other_name>therapy, photodynamic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>therapeutic bronchoscopy</intervention_name>
    <description>Undergo therapeutic bronchoscopy for endoscopic debridement</description>
    <arm_group_label>Treatment (PDT using HPPH)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with biopsy confirmed carcinoma-in-situ (CIS) or microinvasive lung cancer&#xD;
&#xD;
          -  Patients may have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma&#xD;
&#xD;
          -  Patients may have received prior therapy for lung cancer of any type, e.g.&#xD;
             chemotherapy, radiation therapy&#xD;
&#xD;
          -  Patients must have no contraindications for bronchoscopy&#xD;
&#xD;
          -  Female patients must not be pregnant and must be practicing a medically acceptable&#xD;
             form of birth control, be sterile or post-menopausal&#xD;
&#xD;
          -  Patients must have a Karnofsky scale 50 or above (Eastern Cooperative Oncology Group&#xD;
             [ECOG] 0-2)&#xD;
&#xD;
          -  Patients must sign an Informed Consent according to Food and Drug Administration (FDA)&#xD;
             guidelines acceptable to the Roswell Park Cancer Institute (RPCI) Institutional Review&#xD;
             Board (IRB)&#xD;
&#xD;
          -  Patients with underlying lung disease must be judged (by the principal investigator)&#xD;
             able to with stand mucous/debris formation at the site of treatment&#xD;
&#xD;
          -  Definition of CIS or microinvasive lung cancer for this protocol: the lesion will be&#xD;
             radiographically occult and not definable by conventional computed tomography (CT) of&#xD;
             the chest; the lesion may or may not be invisible on white light bronchoscopy, but is&#xD;
             definable and photographable on lung imaging fluorescence endoscope (LIFE)&#xD;
             bronchoscopy; biopsies of the lesion must indicate no evidence of invasion beyond&#xD;
             cartilage on histopathology; the lesion may, however, be invasive through the basement&#xD;
             membrane (microinvasive carcinoma)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds&#xD;
&#xD;
          -  White blood cells (WBC) &lt; 4000&#xD;
&#xD;
          -  Platelet count &lt; 100,000&#xD;
&#xD;
          -  Prothrombin time exceeding 1.5 times the upper normal limit&#xD;
&#xD;
          -  Total serum bilirubin &gt; 3.0 mg/dl&#xD;
&#xD;
          -  Serum creatinine &gt; 3.0 mg/dl&#xD;
&#xD;
          -  Alkaline phosphatase (hepatic) or serum glutamic oxaloacetic transaminase (SGOT) &gt; 3&#xD;
             times the upper normal limit&#xD;
&#xD;
          -  Severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the&#xD;
             investigator preclude multiple bronchoscopies or partial central airway obstruction&#xD;
             from mucous/debris formation&#xD;
&#xD;
          -  Any evidence of worsening pulmonary symptoms or COPD exacerbation&#xD;
&#xD;
          -  Evidence of major pulmonary vessel encasement on CT scan of the chest&#xD;
&#xD;
          -  Myocardial infarction (Ml) or unstable angina in the previous 6 months&#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>Samjot Dhillon</last_name>
    <role>Principal Investigator</role>
    <affiliation>Roswell Park Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>July 30, 2014</last_update_submitted>
  <last_update_submitted_qc>July 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2014</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>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Adenocarcinoma of Lung</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/NCT01668823
org study id: I 05903
secondary id: NCI-2010-02114
nct id: NCT01668823
lead sponsor: 
collaborator: 
has dmc: Yes
This phase I trial is studying the side effects and best dose of photodynamic therapy using
      HPPH in treating patients with lung cancer. Photodynamic therapy uses a drug, such as HPPH,
      that becomes active when it is exposed to a certain kind of light. When the drug is active,
      cancer cells are killed.
PRIMARY OBJECTIVES:

      I. To determine maximally tolerated light dose (MTID). Identify systemic and normal tissue
      toxicity using 2-[hexyloxyethyl)-2-devinyl pyropheophorbide-a (HPPH) for photodynamic therapy
      in patients with bronchogenic carcinoma-in-situ (CIS) or microinvasive carcinoma.

      SECONDARY OBJECTIVES:

      I. To study tumor response in patients with bronchogenic carcinoma-in-situ (CIS) or
      bronchogenic microinvasive carcinoma.

      OUTLINE: This is a dose-escalation study.

      Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients then photodynamic
      therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for
      endoscopic debridement on day 5.

      After completion of study treatment, patients are followed up at 4-6 weeks, 6 months, and
      then periodically for at least 2 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MTID
time frame: Up to 2 years
description: Defined as the dose at which =< 1 out of 6 patients experiences dose-limiting toxicity.
measure: Systemic toxicity according to NCI Common Toxicity Criteria version 2
time frame: Up to 6 months
measure: PDT-related normal tissue toxicity
time frame: Up to 6 months
description: Assessed by a scale with grades 0-3 being acceptable, grade 4 being unacceptable, and grade 5 being stopping study.
measure: Objective tumor response
time frame: Up to 6 months
arm group label: Treatment (PDT using HPPH)
arm group type: Experimental
description: Patients receive HPPH IV over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.
intervention type: Drug
intervention name: HPPH
description: Given IV
arm group label: Treatment (PDT using HPPH)
other name: Photochlor
intervention type: Drug
intervention name: photodynamic therapy
description: Undergo photodynamic therapy with HPPH
arm group label: Treatment (PDT using HPPH)
other name: Light Infusion Therapy™
other name: PDT
other name: therapy, photodynamic
intervention type: Procedure
intervention name: therapeutic bronchoscopy
description: Undergo therapeutic bronchoscopy for endoscopic debridement
arm group label: Treatment (PDT using HPPH)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samjot Dhillon
role: Principal Investigator
affiliation: Roswell Park Cancer Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Adenocarcinoma of Lung