<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/NCT01718223</url>
  </required_header>
  <id_info>
    <org_study_id>I 217512</org_study_id>
    <secondary_id>NCI-2012-01879</secondary_id>
    <nct_id>NCT01718223</nct_id>
  </id_info>
  <brief_title>Photodynamic Therapy Using Temoporfin Before Surgery in Treating Patients With Recurrent Oral Cavity or Oropharyngeal Cancer</brief_title>
  <official_title>A Pilot Study of Interstitial Photodynamic Therapy for Recurrent Squamous Cell Carcinoma of the Oropharynx and Oral Cavity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Biolitec Pharma Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Roswell Park Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies photodynamic therapy using temoporfin before surgery in&#xD;
      treating patients with recurrent oral cavity or oropharyngeal cancer. Photodynamic therapy&#xD;
      uses a drug, such as temoporfin, that is absorbed by tumor cells. The drug becomes active&#xD;
      when it is exposed to light. When the drug is active, tumor cells are killed. Giving&#xD;
      photodynamic therapy using temoporfin before surgery may make the tumor smaller and reduce&#xD;
      the amount of normal tissue that needs to be removed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the toxicity of dose regimen using the Cancer Therapy Evaluation Program (CTEP)&#xD;
      National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version&#xD;
      4.0).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Quantify the relationship between the measured intra-tumor light dose and the pathological&#xD;
      tumor response.&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. Simulate light dose distribution within the treated tumor. II. Immune markers.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive temoporfin intravenously (IV) over at least 6 minutes on day 1 and undergo&#xD;
      interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical&#xD;
      resection.&#xD;
&#xD;
      After completion of study treatment, patients are followed for 3 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    implementation issues&#xD;
  </why_stopped>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 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>Frequency of adverse events, graded according to NCI CTCAE version 4.0</measure>
    <time_frame>Up to 30 days after surgical resection</time_frame>
    <description>The frequency of toxicities will be tabulated by grade.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Light dose-volume histograms (DVH), defined as the overall light dose (joules) that was delivered to the tumor volume throughout the therapy with the light dosimetry system</measure>
    <time_frame>Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of the viable/nonviable tissue in the resected tumor, ex vivo</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>The area of viable and necrotic tumor will be measured by the number of field of view (1 FOV = 0.196 mm^2), microscopic area using a 40x objective.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity</condition>
  <condition>Recurrent Squamous Cell Carcinoma of the Oropharynx</condition>
  <condition>Recurrent Verrucous Carcinoma of the Oral Cavity</condition>
  <condition>Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity</condition>
  <condition>Stage I Squamous Cell Carcinoma of the Oropharynx</condition>
  <condition>Stage I Verrucous Carcinoma of the Oral Cavity</condition>
  <condition>Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity</condition>
  <condition>Stage II Squamous Cell Carcinoma of the Oropharynx</condition>
  <condition>Stage II Verrucous Carcinoma of the Oral Cavity</condition>
  <condition>Tongue Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment (interstitial photodynamic therapy using temoporfin)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive temoporfin IV over at least 6 minutes on day 1 and undergo interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical resection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>photodynamic therapy</intervention_name>
    <description>Undergo interstitial photodynamic therapy using temoporfin</description>
    <arm_group_label>Treatment (interstitial photodynamic therapy using temoporfin)</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 conventional surgery</intervention_name>
    <description>Undergo surgical resection</description>
    <arm_group_label>Treatment (interstitial photodynamic therapy using temoporfin)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (interstitial photodynamic therapy using temoporfin)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>temoporfin</intervention_name>
    <description>Undergo interstitial photodynamic therapy using temoporfin</description>
    <arm_group_label>Treatment (interstitial photodynamic therapy using temoporfin)</arm_group_label>
    <other_name>Foscan</other_name>
    <other_name>m-tetrahydroxyphenyl-chlorin</other_name>
    <other_name>mTHPC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of =&lt; 2&#xD;
&#xD;
          -  Histologically confirmed recurrent or T2/T3/T4 squamous cell carcinoma of the&#xD;
             oropharynx or oral cavity that are amenable to surgery&#xD;
&#xD;
          -  Tumor accessible for unrestricted illumination for interstitial photodynamic therapy&#xD;
             (PDT) (accessibility as determined by the physician)&#xD;
&#xD;
          -  Life expectancy of at least 6 months in the judgment of the physician&#xD;
&#xD;
          -  Blood urea nitrogen (BUN) =&lt; upper limit of normal (ULN)&#xD;
&#xD;
          -  White blood count &gt; 3,000 per microliter or&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt; 1500 per microliter&#xD;
&#xD;
          -  Serum calcium within normal limits; note: serum calcium will be corrected for low&#xD;
             albumin, if necessary&#xD;
&#xD;
          -  Subjects of child-bearing potential must agree to use adequate contraceptive methods&#xD;
             (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry&#xD;
             and for the duration of study participation; should a woman become pregnant or suspect&#xD;
             she is pregnant while she or her partner is participating in this study, she should&#xD;
             inform her treating physician immediately&#xD;
&#xD;
          -  Subject or legal representative must understand the investigational nature of this&#xD;
             study and sign an Institutional Review Board approved written informed consent form&#xD;
             prior to receiving any study related procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have had radiotherapy within the last 3 months&#xD;
&#xD;
          -  Subjects with known brain metastases should be excluded from this clinical trial&#xD;
&#xD;
          -  Tumor invading a major blood vessel (such as the carotid artery)&#xD;
&#xD;
          -  Tumor invading the skull base&#xD;
&#xD;
          -  Subjects with ophthalmic disease&#xD;
&#xD;
          -  Tumor is not clearly shown on an imaging scan/location and extension of tumor that&#xD;
             precludes effective PDT, in the judgment of the primary investigator (PI)&#xD;
&#xD;
          -  Location and extension of the tumor precludes an effective interstitial photodynamic&#xD;
             therapy (iPDT)&#xD;
&#xD;
          -  Patients with known hypersensitivity to porphyrins or with porphyria&#xD;
&#xD;
          -  Has distant metastasis that decreases life expectancy to less than 6 months&#xD;
&#xD;
          -  Uncontrolled intercurrent 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;
&#xD;
          -  Pregnant or nursing female subjects&#xD;
&#xD;
          -  Unwilling or unable to follow protocol requirements and the light exposure precautions&#xD;
&#xD;
          -  Any condition which in the investigator's opinion deems the subject an unsuitable&#xD;
             candidate to receive study drug&#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>Hassan Arshad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Roswell Park Cancer Institute</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>September 2, 2014</last_update_submitted>
  <last_update_submitted_qc>September 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 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>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Oropharyngeal Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Verrucous</mesh_term>
    <mesh_term>Tongue Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Temoporfin</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/NCT01718223
org study id: I 217512
secondary id: NCI-2012-01879
nct id: NCT01718223
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This pilot clinical trial studies photodynamic therapy using temoporfin before surgery in
      treating patients with recurrent oral cavity or oropharyngeal cancer. Photodynamic therapy
      uses a drug, such as temoporfin, that is absorbed by tumor cells. The drug becomes active
      when it is exposed to light. When the drug is active, tumor cells are killed. Giving
      photodynamic therapy using temoporfin before surgery may make the tumor smaller and reduce
      the amount of normal tissue that needs to be removed.
PRIMARY OBJECTIVES:

      I. To assess the toxicity of dose regimen using the Cancer Therapy Evaluation Program (CTEP)
      National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version
      4.0).

      SECONDARY OBJECTIVES:

      I. Quantify the relationship between the measured intra-tumor light dose and the pathological
      tumor response.

      TERTIARY OBJECTIVES:

      I. Simulate light dose distribution within the treated tumor. II. Immune markers.

      OUTLINE:

      Patients receive temoporfin intravenously (IV) over at least 6 minutes on day 1 and undergo
      interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical
      resection.

      After completion of study treatment, patients are followed for 3 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Frequency of adverse events, graded according to NCI CTCAE version 4.0
time frame: Up to 30 days after surgical resection
description: The frequency of toxicities will be tabulated by grade.
measure: Light dose-volume histograms (DVH), defined as the overall light dose (joules) that was delivered to the tumor volume throughout the therapy with the light dosimetry system
time frame: Day 3
measure: Ratio of the viable/nonviable tissue in the resected tumor, ex vivo
time frame: Up to 6 weeks
description: The area of viable and necrotic tumor will be measured by the number of field of view (1 FOV = 0.196 mm^2), microscopic area using a 40x objective.
arm group label: Treatment (interstitial photodynamic therapy using temoporfin)
arm group type: Experimental
description: Patients receive temoporfin IV over at least 6 minutes on day 1 and undergo interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical resection.
intervention type: Drug
intervention name: photodynamic therapy
description: Undergo interstitial photodynamic therapy using temoporfin
arm group label: Treatment (interstitial photodynamic therapy using temoporfin)
other name: Light Infusion Therapy™
other name: PDT
other name: therapy, photodynamic
intervention type: Procedure
intervention name: therapeutic conventional surgery
description: Undergo surgical resection
arm group label: Treatment (interstitial photodynamic therapy using temoporfin)
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Treatment (interstitial photodynamic therapy using temoporfin)
intervention type: Drug
intervention name: temoporfin
description: Undergo interstitial photodynamic therapy using temoporfin
arm group label: Treatment (interstitial photodynamic therapy using temoporfin)
other name: Foscan
other name: m-tetrahydroxyphenyl-chlorin
other name: mTHPC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hassan Arshad, MD
role: Principal Investigator
affiliation: Roswell Park Cancer Institute
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Oropharyngeal Neoplasms
mesh term: Carcinoma, Verrucous
mesh term: Tongue Neoplasms
mesh term: Recurrence
mesh term: Temoporfin