<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/NCT01692691</url>
  </required_header>
  <id_info>
    <org_study_id>12-10</org_study_id>
    <nct_id>NCT01692691</nct_id>
  </id_info>
  <brief_title>Dacarbazine and Carmustine in Metastatic Melanoma</brief_title>
  <official_title>Phase II Trial of Sequenced Chemotherapy With Dacarbazine and Carmustine With Neulasta® Support in Previously Treated 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether dacarbazine and carmustine at the doses and&#xD;
      schedule used in this study will help to increase tumor shrinkage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this phase II trial, patients with stage IV melanoma will be treated with dacarbazine and&#xD;
      carmustine commonly used in this cancer, but given using a schedule that might theoretically&#xD;
      improve on this combination. Patients on this study will be assessed in terms of toxicity,&#xD;
      response rate, median duration of response, median time to disease progression, and median&#xD;
      survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI decision&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 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>Progression Free Survival</measure>
    <time_frame>8 weeks</time_frame>
    <description>Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response Rate</measure>
    <time_frame>8 weeks</time_frame>
    <description>To determine the response rate after being treated with Dacarbazine Carmustine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Duration of Response</measure>
    <time_frame>8 weeks</time_frame>
    <description>To determine the median duration of response for patients who received Dacarbazine and Carmustine</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Melanoma Metastatic</condition>
  <arm_group>
    <arm_group_label>Dacarbazine, carmustine, neulasta</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dacarbazine</intervention_name>
    <description>Dacarbazine IV - Day 1</description>
    <arm_group_label>Dacarbazine, carmustine, neulasta</arm_group_label>
    <other_name>DTIC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carmustine</intervention_name>
    <description>Carmustine IV- Day 2</description>
    <arm_group_label>Dacarbazine, carmustine, neulasta</arm_group_label>
    <other_name>BCNU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neulasta</intervention_name>
    <description>Neulasta SC - Day 3</description>
    <arm_group_label>Dacarbazine, carmustine, neulasta</arm_group_label>
    <other_name>pegfilgrastim</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must have a histologically-proven diagnosis of metastatic malignant melanoma&#xD;
             which has progressed on at least one prior systemic therapy.&#xD;
&#xD;
          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 and&#xD;
             estimated survival of at least 3 months.&#xD;
&#xD;
          3. Patients must be felt to have recovered from effects of prior cancer therapy, such as&#xD;
             past expected leukocyte nadir for chemotherapy (&gt; 2 weeks).&#xD;
&#xD;
          4. Absolute granulocyte count of at least 1500/mm3; hemoglobin of at least 9 gm/dl;&#xD;
             platelet count of at least 100,000/mm3; bilirubin must be less than 1.5 mg/dl; ALT and&#xD;
             AST must be less than 3 times the upper limit of normal; creatinine must be less than&#xD;
             or equal to 1.8 mg/dl.&#xD;
&#xD;
          5. Women of childbearing potential must have a negative pregnancy test and adequate&#xD;
             precautions to prevent pregnancy during treatment must be taken.&#xD;
&#xD;
          6. Patient consent must be obtained prior to entrance onto study.&#xD;
&#xD;
          7. Patients must have no evidence of significant cardiovascular disease including history&#xD;
             of recent (&lt; 6 months) myocardial infarction, uncompensated congestive heart failure,&#xD;
             uncontrolled angina or cerebrovascular accident.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of significant cardiovascular disease including history of recent (&lt; 6&#xD;
             months) myocardial infarction, uncompensated congestive heart failure, uncontrolled&#xD;
             angina, or cerebrovascular accident.&#xD;
&#xD;
          2. Prior history of psychiatric disorder that could be exacerbated by or which could&#xD;
             preclude completion of this therapy.&#xD;
&#xD;
          3. Pregnancy or lactation.&#xD;
&#xD;
          4. Prior chemotherapy with carmustine&#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>CTCA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Western Regional Medical Center</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>March 2018</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <results_first_submitted>January 1, 2016</results_first_submitted>
  <results_first_submitted_qc>January 1, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 2, 2016</results_first_posted>
  <last_update_submitted>March 8, 2018</last_update_submitted>
  <last_update_submitted_qc>March 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Melanoma Metastatic</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>Dacarbazine</mesh_term>
    <mesh_term>Carmustine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dacarbazine Carmustine</title>
          <description>All patients received chemotherapy with Dacarbazine and Carmustine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Received Treatment</title>
          <description>Dacarbazine Carmustine participants</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
          </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="1"/>
                  </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression Free Survival</title>
        <description>Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy</description>
        <time_frame>8 weeks</time_frame>
        <population>Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.&quot;After much effort, results were not able to be retained.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants 8 Week Survival.</title>
            <description>Number of participants who received Dacarbazine + Carmustine Progression Free survival at 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival</title>
          <description>Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy</description>
          <population>Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.&quot;After much effort, results were not able to be retained.</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>Response Rate</title>
        <description>To determine the response rate after being treated with Dacarbazine Carmustine</description>
        <time_frame>8 weeks</time_frame>
        <population>Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.&quot;After much effort, results were not able to be retained.</population>
        <group_list>
          <group group_id="O1">
            <title>Response Rate</title>
            <description>Dacarbazine Carmustine</description>
          </group>
        </group_list>
        <measure>
          <title>Response Rate</title>
          <description>To determine the response rate after being treated with Dacarbazine Carmustine</description>
          <population>Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.&quot;After much effort, results were not able to be retained.</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>To determine the median duration of response for patients who received Dacarbazine and Carmustine</description>
        <time_frame>8 weeks</time_frame>
        <population>Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.&quot;After much effort, results were not able to be retained.</population>
        <group_list>
          <group group_id="O1">
            <title>Dacarbazine Carmustine</title>
            <description>All patients received chemotherapy with Dacarbazine and Carmustine</description>
          </group>
        </group_list>
        <measure>
          <title>Median Duration of Response</title>
          <description>To determine the median duration of response for patients who received Dacarbazine and Carmustine</description>
          <population>Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.&quot;After much effort, results were not able to be retained.</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>Received Treatment</title>
          <description>Number of Participants who received Dacarbazine Carmustine</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>gastroesophageal reflux</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Arthalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </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/NCT01692691
org study id: 12-10
nct id: NCT01692691
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether dacarbazine and carmustine at the doses and
      schedule used in this study will help to increase tumor shrinkage.
In this phase II trial, patients with stage IV melanoma will be treated with dacarbazine and
      carmustine commonly used in this cancer, but given using a schedule that might theoretically
      improve on this combination. Patients on this study will be assessed in terms of toxicity,
      response rate, median duration of response, median time to disease progression, and median
      survival.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival
time frame: 8 weeks
description: Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy
measure: Response Rate
time frame: 8 weeks
description: To determine the response rate after being treated with Dacarbazine Carmustine
measure: Median Duration of Response
time frame: 8 weeks
description: To determine the median duration of response for patients who received Dacarbazine and Carmustine
arm group label: Dacarbazine, carmustine, neulasta
arm group type: Experimental
description: Dacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3
intervention type: Drug
intervention name: Dacarbazine
description: Dacarbazine IV - Day 1
arm group label: Dacarbazine, carmustine, neulasta
other name: DTIC
intervention type: Drug
intervention name: Carmustine
description: Carmustine IV- Day 2
arm group label: Dacarbazine, carmustine, neulasta
other name: BCNU
intervention type: Drug
intervention name: Neulasta
description: Neulasta SC - Day 3
arm group label: Dacarbazine, carmustine, neulasta
other name: pegfilgrastim
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jordan Waypa, FNP
role: Study Director
affiliation: CTCA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Dacarbazine
mesh term: Carmustine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 