<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/NCT01679470</url>
  </required_header>
  <id_info>
    <org_study_id>NBI-LC-001</org_study_id>
    <nct_id>NCT01679470</nct_id>
  </id_info>
  <brief_title>Efficacy Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors</brief_title>
  <official_title>A Pilot Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanospectra Biosciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanospectra Biosciences, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, single-center, single-dose efficacy pilot study of AuroLase Therapy in&#xD;
      the treatment of subjects with primary and/or metastatic tumors of the lung where there is&#xD;
      airway obstruction. In this study patients will be given a systemic IV infusion of particles&#xD;
      and a subsequent escalating dose of laser radiation delivered by optical fiber via&#xD;
      bronchoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</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>Number of participants not manifesting a thermal lesion</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">1</enrollment>
  <condition>Primary or Metastatic Lung Tumors</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AuroLase Therapy</intervention_name>
    <description>Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have documented histological or cytological evidence of tumor(s) of the&#xD;
             lung.&#xD;
&#xD;
          -  Subjects must have one or more primary or metastatic tumors of the lung which have at&#xD;
             least 10 mm in long axis as evaluated by spiral CT scan evaluation performed within&#xD;
             last 30 days.&#xD;
&#xD;
          -  Target lesions should be accessible to examination (examination by fiberoptic&#xD;
             bronchoscopy is permitted) and to biopsy.&#xD;
&#xD;
          -  Each index lesion should be large enough to provide at least 6 mg of tumor tissue by&#xD;
             biopsy for assessment by neutron activation analysis.&#xD;
&#xD;
          -  Tumors must be measurable according to RECIST criteria.&#xD;
&#xD;
          -  Subjects must have ECOG Performance Score of 0, 1 or 2.&#xD;
&#xD;
          -  Subjects must be ≥ 18 years of age.&#xD;
&#xD;
          -  Subjects or their legal representative must be able to read, understand and sign an&#xD;
             informed consent.&#xD;
&#xD;
          -  Adequate renal function as evidenced by serum creatinine ≤ 2.0 mg/dL.&#xD;
&#xD;
          -  Adequate hepatic function as evidenced by: Serum total bilirubin ≤ 2.0 mg/dL; Alkaline&#xD;
             phosphatase ≤ 2X the ULN for the reference lab; SGOT/SGPT ≤ 2X the ULN for the&#xD;
             reference lab.&#xD;
&#xD;
          -  Women of childbearing potential must agree to use an effective form of contraception&#xD;
             during the study and for 90 days following treatment (an effective form of&#xD;
             contraception is an oral contraceptive or a double barrier method). Women who are NOT&#xD;
             of childbearing potential are those who have undergone a bilateral oophorectomy or who&#xD;
             have undergone menopause, defined as an absence of a menstrual cycle for 12&#xD;
             consecutive months.&#xD;
&#xD;
          -  Negative pregnancy test for women of childbearing potential.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with known hypersensitivity to any of the components of the PEGylated&#xD;
             AuroShell suspension (polyethylene glycol, gold).&#xD;
&#xD;
          -  Patients who are pregnant and/or lactating.&#xD;
&#xD;
          -  Patients who have undergone splenectomy.&#xD;
&#xD;
          -  Subjects who are receiving concurrent investigational therapy or who have received&#xD;
             investigational therapy within the 30 days prior to AuroShell infusion&#xD;
             (investigational therapy is defined as treatment for which there is currently no&#xD;
             regulatory authority approved indication).&#xD;
&#xD;
          -  Subjects with evidence of an active bacterial infection or with a fever ≥ 38.5 ºC&#xD;
             (101.3 ºF) within 3 days of the first scheduled day of dosing.&#xD;
&#xD;
          -  Subject who has had a course of radiotherapy in the treatment area within the 30 days&#xD;
             prior to AuroShell infusion.&#xD;
&#xD;
          -  Subject who has had a course of chemotherapy or other anti-neoplastic therapy in the&#xD;
             30 days prior to AuroShell infusion.&#xD;
&#xD;
          -  Life expectancy of less than 3 months.&#xD;
&#xD;
          -  Any other medical condition, including mental illness or substance abuse, deemed by&#xD;
             the Investigator to be likely to interfere with a subject's ability to sign informed&#xD;
             consent, cooperate and participate in the study, or interfere with the interpretation&#xD;
             of the results.&#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>Glenn Goodrich, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Nanospectra Biosciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cancer Treatment Centers of America Eastern Regional Medical Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>November 2, 2016</last_update_submitted>
  <last_update_submitted_qc>November 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cancer</keyword>
  <keyword>lung</keyword>
  <keyword>laser</keyword>
  <keyword>ablation</keyword>
  <keyword>airway obstruction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung 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/NCT01679470
org study id: NBI-LC-001
nct id: NCT01679470
lead sponsor: 
has dmc: Yes
This is an open-label, single-center, single-dose efficacy pilot study of AuroLase Therapy in
      the treatment of subjects with primary and/or metastatic tumors of the lung where there is
      airway obstruction. In this study patients will be given a systemic IV infusion of particles
      and a subsequent escalating dose of laser radiation delivered by optical fiber via
      bronchoscopy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants not manifesting a thermal lesion
time frame: 6 months
intervention type: Device
intervention name: AuroLase Therapy
description: Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Glenn Goodrich, PhD
role: Study Director
affiliation: Nanospectra Biosciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms