<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/NCT01702896</url>
  </required_header>
  <id_info>
    <org_study_id>12-07</org_study_id>
    <nct_id>NCT01702896</nct_id>
  </id_info>
  <brief_title>Interleukin-2 in Metastatic Melanoma</brief_title>
  <official_title>Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Melanoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Regional Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western Regional Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine whether Interleukin-2 at the dose and schedule will help to increase tumor&#xD;
      shrinkage&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this phase II trial, the previously described IL-2 schedule (daily IL-2 for 5 days (per&#xD;
      week) every 3 weeks) will be tested in a larger cohort of patients with melanoma to attempt&#xD;
      to determine the response rate, median duration of response, and median survival. The dose&#xD;
      intensity of this schedule would allow a patient treated on this regimen to achieve the&#xD;
      target threshold (&gt; 1440 million IU/m2/year).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI Decision&#xD;
  </why_stopped>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 2</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>Response Rate</measure>
    <time_frame>Measured until Disease Progression or death from any cause up to 2 years</time_frame>
    <description>Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Median Duration of Response</measure>
    <time_frame>Measured until Disease Progression or death from any cause up to 2 years</time_frame>
    <description>Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors [RECIST] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Survival</measure>
    <time_frame>From time of study entry until death, up to 10 years</time_frame>
    <description>Measured from date of entry on study until date of death</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Melanoma Metastatic</condition>
  <arm_group>
    <arm_group_label>Interleukin-2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interleukin-2 will be used in this group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Interleukin-2</intervention_name>
    <description>Interleukin-2</description>
    <arm_group_label>Interleukin-2</arm_group_label>
    <other_name>IL2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must have a histologic diagnosis of metastatic melanoma. Patients may have&#xD;
             received prior systemic therapy or may be previously untreated.&#xD;
&#xD;
          2. Patients must have bi-dimensional measurable disease on physical exam or radiologic&#xD;
             studies.&#xD;
&#xD;
          3. ECOG performance status of 0 or 1 and estimated survival of at least 3 months.&#xD;
&#xD;
          4. White blood count of &gt; 3500/mm3, platelet count &gt; 100,000/mm3, hemoglobin &gt; 9.0 gm/dl;&#xD;
             bilirubin, ALT, AST &lt; 3 x upper limit of normal; serum creatinine &lt; 2.0 mg/dl.&#xD;
&#xD;
          5. Patients must undergo a low-level cardiac stress test as a screen for possible&#xD;
             atherosclerotic heart disease. Patients with a positive stress test would be excluded&#xD;
             from this trial.&#xD;
&#xD;
          6. Patients with elevated temperatures &gt; 100.5 F must have sources of occult infection&#xD;
             excluded.&#xD;
&#xD;
          7. Patients must be felt to have recovered from effects of prior therapy, such as &gt; 2&#xD;
             weeks after prior chemotherapy.&#xD;
&#xD;
          8. Patient consent must be obtained prior to entrance onto study.&#xD;
&#xD;
          9. Women of childbearing potential must have a negative pregnancy test and must take&#xD;
             adequate precautions to prevent pregnancy during treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Medical illness requiring corticosteroids or other immunosuppressive agents (such as&#xD;
             cyclosporin or methotrexate.&#xD;
&#xD;
          2. Autoimmune disease such as inflammatory arthritis which could be exacerbated by&#xD;
             immune-based therapy.&#xD;
&#xD;
          3. Prior history of psychiatric disorder which could be exacerbated by interleukin-2.&#xD;
&#xD;
          4. Lactation or pregnancy.&#xD;
&#xD;
          5. Evidence of significant cardiovascular disease including history of recent (&lt; 6 months&#xD;
             prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias&#xD;
             (not due to electrolyte disorder or drug toxicity, for example) beyond occasional&#xD;
             PVC's, angina, positive low-level stress test, or cerebrovascular accident.&#xD;
&#xD;
          6. Current brain metastasis.&#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>Jordan Waypa, FNP</last_name>
    <role>Study Director</role>
    <affiliation>Research Director</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Western Regional Medical Center, Inc.</name>
      <address>
        <city>Goodyear</city>
        <state>Arizona</state>
        <zip>85338</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <results_first_submitted>September 23, 2017</results_first_submitted>
  <results_first_submitted_qc>January 12, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 7, 2018</results_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Metastatic Melanoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interleukin-2</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Interleukin-2</title>
          <description>All patients received Interleukin-2</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Number of Participants</title>
          <description>Treated with Interleukin-2</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Response Rate</title>
        <description>Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).</description>
        <time_frame>Measured until Disease Progression or death from any cause up to 2 years</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Response Rate</title>
            <description>Percentage of patient who received IL-2 that had a positive response to treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Response Rate</title>
          <description>Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Duration of Response</title>
        <description>Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors [RECIST] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.</description>
        <time_frame>Measured until Disease Progression or death from any cause up to 2 years</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Interleukin-2</title>
            <description>Interleukin-2&#xD;
Interleukin-2: Interleukin-2</description>
          </group>
        </group_list>
        <measure>
          <title>Median Duration of Response</title>
          <description>Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors [RECIST] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Survival</title>
        <description>Measured from date of entry on study until date of death</description>
        <time_frame>From time of study entry until death, up to 10 years</time_frame>
        <population>Data was not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Median Survival</title>
            <description>Median survival was measured from date of entry on study until date of death</description>
          </group>
        </group_list>
        <measure>
          <title>Median Survival</title>
          <description>Measured from date of entry on study until date of death</description>
          <population>Data was not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Adverse Events</title>
          <description>Patients receiving Interleukin-2</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jessica L. Coats</name_or_title>
      <organization>Western Regional Medical Center</organization>
      <phone>623-207-3899</phone>
      <email>jessica.coats@ctca-hope.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01702896
org study id: 12-07
nct id: NCT01702896
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
To determine whether Interleukin-2 at the dose and schedule will help to increase tumor
      shrinkage
In this phase II trial, the previously described IL-2 schedule (daily IL-2 for 5 days (per
      week) every 3 weeks) will be tested in a larger cohort of patients with melanoma to attempt
      to determine the response rate, median duration of response, and median survival. The dose
      intensity of this schedule would allow a patient treated on this regimen to achieve the
      target threshold (> 1440 million IU/m2/year).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Response Rate
time frame: Measured until Disease Progression or death from any cause up to 2 years
description: Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).
measure: Median Duration of Response
time frame: Measured until Disease Progression or death from any cause up to 2 years
description: Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors [RECIST] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.
measure: Median Survival
time frame: From time of study entry until death, up to 10 years
description: Measured from date of entry on study until date of death
arm group label: Interleukin-2
arm group type: Experimental
description: Interleukin-2 will be used in this group
intervention type: Drug
intervention name: Interleukin-2
description: Interleukin-2
arm group label: Interleukin-2
other name: IL2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jordan Waypa, FNP
role: Study Director
affiliation: Research Director
facility: 
country: United States
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Interleukin-2
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 