xml: <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/NCT06024603</url>
    </required_header>
    <id_info>
      <org_study_id>CASE5Y22</org_study_id>
      <nct_id>NCT06024603</nct_id>
    </id_info>
    <brief_title>Individualized Treatments in Adults With Relapsed/Refractory Cancers</brief_title>
    <official_title>Individualized Treatments in Adults With Relapsed/Refractory Cancers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Case Comprehensive Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Case Comprehensive Cancer Center</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Resistance to most chemotherapeutic regimens continues to be a major problem, leading to&#xD;
        refractory cancer and relapse. In addition, there are major gaps in understanding of the&#xD;
        molecular hallmarks and drivers of advanced and metastatic cancers, with limited whole genome&#xD;
        sequencing data or longitudinal profiling available to understand genomic drivers of&#xD;
        metastasis and therapy resistance. A personalized cancer medicine approach would address&#xD;
        therapy resistance and cancer metastasis in advanced cancer participants, eliminating the&#xD;
        need to limit treatment improvements to a particular cancer type or patient demographic.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Treatment itself will not be given as part of this trial. The results of the drug sensitivity&#xD;
        test (DST) and genomic screening will be used to inform treating physician about&#xD;
        participant-specific drug sensitivity or resistance guiding best therapy choices. Standard&#xD;
        therapy will be implemented, when possible, with an option to add the personalized (most&#xD;
        effective response in vitro) drug from the investigational platform for enhanced treatment in&#xD;
        participants. The physician will decide which treatment will be most appropriate for each&#xD;
        case. All participants will need to be consented separately for any subsequent&#xD;
        investigational treatment if no standard treatment options are available.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">November 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2025</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Treatment recommendation feasibility</measure>
      <time_frame>Up to 4 weeks post-treatment</time_frame>
      <description>Primary objective is to determine feasibility of providing treatment recommendations to relapsed and refractory adult cancer patients based on ex vivo drug sensitivity testing (DST). Feasibility will be demonstrated if it is possible to recommend treatment within 4 weeks in at least 22 of 36 participants (62.5%).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment recommendation feasibility</measure>
      <time_frame>Up to 4 weeks post-treatment</time_frame>
      <description>Primary objective is to determine feasibility of providing treatment recommendations to relapsed and refractory adult cancer patients based on genomic profiling. Feasibility will be demonstrated if it is possible to recommend treatment within 4 weeks in at least 22 of 36 participants (62.5%).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Treatment responsiveness</measure>
      <time_frame>Up tp 1 year post-treatment</time_frame>
      <description>Treatment responsiveness will be measured by comparing individual outcomes of adult participants with relapsed and refractory cancers treated with DST-guided therapy to non-DST guided (conventional) therapy. To address this goal, the overall response rate will be calculated. A responder to the treatment will be defined as any patient who achieves a best response of &quot;partial response&quot; or complete response&quot; during the study period.Evaluable patients who demonstrate a complete or partial response confirmed by physician's review before receiving non-protocol anti- cancer therapy will be considered a responder. All other evaluable patients will be considered non- responder. Outcomes will be observed during treatment and follow-up for one year post-treatment or until disease progression, death, or withdrawal, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease-free survival</measure>
      <time_frame>Up tp 1 year post-treatment</time_frame>
      <description>Disease-free survival will be measured by comparing individual outcomes of adult participants with relapsed and refractory cancers treated with DST-guided therapy to non-DST guided (conventional) therapy. DFS will be defined as time from start of treatment to even (treatment failure, relapse, second malignancy, death) or last follow-up for those who are event-free. Outcomes will be observed during treatment and follow-up for one year post-treatment or until disease progression, death, or withdrawal, whichever occurs first.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Refractory Cancer</condition>
    <condition>Relapsed Cancer</condition>
    <arm_group>
      <arm_group_label>Drug Sensitivity Testing</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The results of the DST and genomic screening will be used to inform treating physician about participant-specific drug sensitivity or resistance guiding best therapy choices. Standard therapy will be implemented, when possible, with an option to add the personalized (most effective response in vitro) drug from the investigational platform for enhanced treatment in participants. The physician will decide which treatment will be most appropriate for each case. All participants will need to be consented separately for any subsequent investigational treatment if no standard treatment options are available.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Drug Sensitivity Test (DST)</intervention_name>
      <description>Refractory cancer cells will be collected from participants and subjected to single-drug testing while DNA is simultaneously sent for targeted gene sequencing. Drug sensitivity scores from the tests will become available for a final list of therapeutic options ranked best in order of preference together with suggested doses and schedules.</description>
      <arm_group_label>Drug Sensitivity Testing</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants aged 18 years or older at the time of enrollment on this study of any&#xD;
               gender, race, or ethnicity.&#xD;
  &#xD;
            -  Patients with suspected or confirmed diagnosis of recurrent or refractory cancer.&#xD;
  &#xD;
            -  Participants who have undergone at least two lines of previous therapy.&#xD;
  &#xD;
            -  Participants who are scheduled for or have recently had biopsy or tumor excised (solid&#xD;
               tumors) or bone marrow aspirate (blood cancers).&#xD;
  &#xD;
            -  Participants willing to have a blood draw or buccal swab done for the purposes of&#xD;
               genetic testing.&#xD;
  &#xD;
            -  Participants willing to sign informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants who do not have malignant tissue available and accessible.&#xD;
  &#xD;
            -  Participants for whom the amount of excised malignant tissue is not sufficient for the&#xD;
               ex vivo drug testing and/or genetic profiling.&#xD;
  &#xD;
            -  Participants with newly diagnosed tumors and tumors that have high (&gt;90%) cure rate&#xD;
               with safe standard therapy.&#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>Jorge Manrique-Succar, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Lerner College of Medicine, Cleveland Clinic Florida</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jorge Manrique-Succar, MD</last_name>
      <phone>(954) 659-5000</phone>
      <email>manriqj@ccf.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Lerner College of Medicine: Cleveland Clinic Florida</name>
        <address>
          <city>Weston</city>
          <state>Florida</state>
          <zip>33331</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jorge Manrique-Succar, MD</last_name>
        <phone>954-659-5000</phone>
        <email>manriqj@ccf.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024603
  org study id: CASE5Y22
  nct id: NCT06024603
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Resistance to most chemotherapeutic regimens continues to be a major problem, leading to
        refractory cancer and relapse. In addition, there are major gaps in understanding of the
        molecular hallmarks and drivers of advanced and metastatic cancers, with limited whole genome
        sequencing data or longitudinal profiling available to understand genomic drivers of
        metastasis and therapy resistance. A personalized cancer medicine approach would address
        therapy resistance and cancer metastasis in advanced cancer participants, eliminating the
        need to limit treatment improvements to a particular cancer type or patient demographic.
  Treatment itself will not be given as part of this trial. The results of the drug sensitivity
        test (DST) and genomic screening will be used to inform treating physician about
        participant-specific drug sensitivity or resistance guiding best therapy choices. Standard
        therapy will be implemented, when possible, with an option to add the personalized (most
        effective response in vitro) drug from the investigational platform for enhanced treatment in
        participants. The physician will decide which treatment will be most appropriate for each
        case. All participants will need to be consented separately for any subsequent
        investigational treatment if no standard treatment options are available.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Treatment recommendation feasibility
  time frame: Up to 4 weeks post-treatment
  description: Primary objective is to determine feasibility of providing treatment recommendations to relapsed and refractory adult cancer patients based on ex vivo drug sensitivity testing (DST). Feasibility will be demonstrated if it is possible to recommend treatment within 4 weeks in at least 22 of 36 participants (62.5%).
  measure: Treatment recommendation feasibility
  time frame: Up to 4 weeks post-treatment
  description: Primary objective is to determine feasibility of providing treatment recommendations to relapsed and refractory adult cancer patients based on genomic profiling. Feasibility will be demonstrated if it is possible to recommend treatment within 4 weeks in at least 22 of 36 participants (62.5%).
  measure: Treatment responsiveness
  time frame: Up tp 1 year post-treatment
  description: Treatment responsiveness will be measured by comparing individual outcomes of adult participants with relapsed and refractory cancers treated with DST-guided therapy to non-DST guided (conventional) therapy. To address this goal, the overall response rate will be calculated. A responder to the treatment will be defined as any patient who achieves a best response of "partial response" or complete response" during the study period.Evaluable patients who demonstrate a complete or partial response confirmed by physician's review before receiving non-protocol anti- cancer therapy will be considered a responder. All other evaluable patients will be considered non- responder. Outcomes will be observed during treatment and follow-up for one year post-treatment or until disease progression, death, or withdrawal, whichever occurs first.
  measure: Disease-free survival
  time frame: Up tp 1 year post-treatment
  description: Disease-free survival will be measured by comparing individual outcomes of adult participants with relapsed and refractory cancers treated with DST-guided therapy to non-DST guided (conventional) therapy. DFS will be defined as time from start of treatment to even (treatment failure, relapse, second malignancy, death) or last follow-up for those who are event-free. Outcomes will be observed during treatment and follow-up for one year post-treatment or until disease progression, death, or withdrawal, whichever occurs first.
  arm group label: Drug Sensitivity Testing
  arm group type: Experimental
  description: The results of the DST and genomic screening will be used to inform treating physician about participant-specific drug sensitivity or resistance guiding best therapy choices. Standard therapy will be implemented, when possible, with an option to add the personalized (most effective response in vitro) drug from the investigational platform for enhanced treatment in participants. The physician will decide which treatment will be most appropriate for each case. All participants will need to be consented separately for any subsequent investigational treatment if no standard treatment options are available.
  intervention type: Diagnostic Test
  intervention name: Drug Sensitivity Test (DST)
  description: Refractory cancer cells will be collected from participants and subjected to single-drug testing while DNA is simultaneously sent for targeted gene sequencing. Drug sensitivity scores from the tests will become available for a final list of therapeutic options ranked best in order of preference together with suggested doses and schedules.
  arm group label: Drug Sensitivity Testing
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jorge Manrique-Succar, MD
  role: Principal Investigator
  affiliation: Lerner College of Medicine, Cleveland Clinic Florida
  last name: Jorge Manrique-Succar, MD
  phone: (954) 659-5000
  email: manriqj@ccf.org
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor