<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/NCT03273712</url>
  </required_header>
  <id_info>
    <org_study_id>201708778</org_study_id>
    <secondary_id>R01CA167632</secondary_id>
    <secondary_id>201412770</secondary_id>
    <nct_id>NCT03273712</nct_id>
    <nct_alias>NCT02441088</nct_alias>
  </id_info>
  <brief_title>Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)</brief_title>
  <official_title>Phase II, Dosimetry Guided, Peptide Receptor Radiotherapy (PRRT) Using 90Y-DOTA tyr3-Octreotide (90Y-DOTATOC) in Children and Adults With Neuroendocrine and Other Somatostatin Receptor Positive Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with&#xD;
      somatostatin receptor positive tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with&#xD;
      somatostatin receptor positive tumors. The somatostatin receptor targeting of the therapeutic&#xD;
      will be checked with 68Ga-DOTATOC PET-CT imaging prior to therapy. Treatment consists of 3&#xD;
      cycles, 6-8 weeks apart. Cycle 1 dose is fixed with Cycles 2 and 3 doses to be determined by&#xD;
      dosimetry-based calculation of renal doses from previous cycles not to exceed 23 Gy for the&#xD;
      total renal dose.&#xD;
&#xD;
      The goals of this project are to&#xD;
&#xD;
        1. Demonstrate the safety and efficacy of dosimetry-guided peptide receptor radiotherapy&#xD;
           using 90Y-DOTA-tyr3-Octreotide in patients with neuroendocrine and other somatostatin&#xD;
           receptor expressing tumors.&#xD;
&#xD;
        2. Monitor all adverse events associated with peptide receptor radiotherapy using&#xD;
           90Y-DOTATOC.&#xD;
&#xD;
        3. Establish 68Ga-DOTA-tyr3-Octreotide (68Ga-DOTATOC) or 68Ga-DOTATATE PET/CT as an&#xD;
           accurate technique for diagnosis, staging, treatment targeting, and monitoring response&#xD;
           to 90Y-DOTATOC therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">May 27, 2020</completion_date>
  <primary_completion_date type="Actual">May 27, 2020</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>Frequency of Tumor Response at 9 Months After Last Treatment</measure>
    <time_frame>Baseline through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.</time_frame>
    <description>Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to quantify tumor response by comparison of baseline and last follow-up visit (6-9 months after last treatment) diagnostic CT/MRI scans.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Patients With Grade 4 or Higher Renal Adverse Event.</measure>
    <time_frame>Initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.</time_frame>
    <description>The percentage of patients who experience a grade 4 or higher renal adverse event. Renal adverse events were graded using CTCAE v4.0 criteria.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Patients With Grade 4 or Higher Irreversible Adverse Events</measure>
    <time_frame>Initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.</time_frame>
    <description>The percentage of patients who experience a grade 4 or higher irreversible adverse event. Adverse events were graded using CTCAE v4.0 criteria.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Neuroendocrine Tumors</condition>
  <condition>Meningioma</condition>
  <condition>Neuroblastoma</condition>
  <condition>Medulloblastoma</condition>
  <arm_group>
    <arm_group_label>90Y-DOTA-tyr3-Octreotide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>90Y-DOTA tyr3-Octreotide</intervention_name>
    <description>90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.</description>
    <arm_group_label>90Y-DOTA-tyr3-Octreotide</arm_group_label>
    <other_name>90Y-DOTATOC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan</intervention_name>
    <description>68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.</description>
    <arm_group_label>90Y-DOTA-tyr3-Octreotide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amino Acids</intervention_name>
    <description>This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.</description>
    <arm_group_label>90Y-DOTA-tyr3-Octreotide</arm_group_label>
    <other_name>Lysine and Arginine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Disease not amenable to standard treatment (nonresectable or disease present after one&#xD;
             or more surgeries and/or Sandostatin treatment) or subject has failed existing first&#xD;
             line chemotherapy, biologic therapy, targeted agent therapy or radiation therapy.&#xD;
&#xD;
          2. Participation in Iowa Neuroendocrine Tumor Registry.&#xD;
&#xD;
          3. A pathologically confirmed (histology or cytology) malignant neoplasm with at least&#xD;
             one target lesion that is confirmed by conventional imaging and is determined to&#xD;
             express somatostatin receptors by 68Ga-DOTATOC (TATE) PET within 6 months prior to&#xD;
             treatment with 90Y-DOTATOC.&#xD;
&#xD;
          4. The target lesion is one that either has never received external beam radiation or has&#xD;
             been previously irradiated and has since demonstrated progression. Any local&#xD;
             irradiation of the target lesion or any non-target lesions via external beam,&#xD;
             conformal or stereotactic radiation treatments must have occurred more than 4 weeks&#xD;
             prior to study drug administration. Any full cranial-spinal radiation, whether or not&#xD;
             a target lesion is included in the field, must have occurred more than 3 months prior&#xD;
             to study drug administration.&#xD;
&#xD;
          5. Life expectancy &gt; 2 months at the time of study drug administration.&#xD;
&#xD;
          6. Archival tissue from a previous biopsy will be required.&#xD;
&#xD;
          7. Age ≥ 6 months-90 years at the time of study drug administration.&#xD;
&#xD;
          8. Performance status as determined by Karnofsky ≥ 60 or Lansky Play Scale ≥ 60% at the&#xD;
             time of study drug administration.&#xD;
&#xD;
          9. Completion of Norfolk Quality of Life Questionnaire.&#xD;
&#xD;
         10. Within 7-10 days of study drug administration, patients must have normal organ and&#xD;
             marrow function as defined below:&#xD;
&#xD;
               -  absolute neutrophil count &gt;1000/mm3&#xD;
&#xD;
               -  Platelets &gt;90,000/mm3&#xD;
&#xD;
               -  total bilirubin &lt;3X ULN for age&#xD;
&#xD;
               -  AST(SGOT) &amp; ALT(SGPT) &lt;10X institutional upper limit of normal for age&#xD;
&#xD;
               -  Urinalysis no greater than 1+ hematuria or proteinuria&#xD;
&#xD;
               -  Renal function* Adults(age18 or &gt;): Serum creatinine ≤ 1.2 mg/dl; if serum&#xD;
                  creatinine is &gt;1.2 mg/dL, nuclear GFR will be measured. GFR will need to be ≥ 80&#xD;
                  ml/min/1.73m2 for subjects ≤40 years old, ≥ 70 ml/min/1.73m2 for subjects between&#xD;
                  41-50; ≥ 60 ml/min/1.73m2 for subjects between 51-60; ≥ 50 ml/min/1.73m2 for&#xD;
                  subjects &gt; 60 years old.&#xD;
&#xD;
             Children(age &lt;18): nuclear GFR ≥ 80 mL/min/1.73 m2&#xD;
&#xD;
             * Renal function criteria based on our previous experience with 90Y-DOTATOC therapy&#xD;
             and known changes in GFR with age13,21,33-35&#xD;
&#xD;
         11. The effects of 90Y-DOTA-tyr3-Octreotide on the developing human fetus are unknown. For&#xD;
             this reason and because Class C agents are known to be teratogenic, women and men of&#xD;
             child-bearing potential must agree to use adequate contraception (hormonal or barrier&#xD;
             method of birth control) prior to study entry and for the duration of study&#xD;
             participation. Should a woman become pregnant or suspect she is pregnant while&#xD;
             participating in this study, she should inform her treating physician immediately.&#xD;
&#xD;
         12. Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant women are excluded from this study because 90Y-DOTATOC is a Class C agent&#xD;
             with potential teratogenic or abortifacient effects.&#xD;
&#xD;
          2. Because there is an unknown but potential risk for adverse events in nursing infants&#xD;
             secondary to treatment of the mother with 90Y-DOTATOC, breastfeeding should be&#xD;
             discontinued until 6 weeks after the last administration of study drug.&#xD;
&#xD;
          3. Surgery within 4 weeks of study drug administration.&#xD;
&#xD;
          4. External beam radiation to both kidneys (scatter doses of &lt;500 cGy to a single kidney&#xD;
             or radiation to &lt; 50% of a single kidney is acceptable).&#xD;
&#xD;
          5. Prior PRRT with 90Y-DOTATOC (TATE) or 177Lu-DOTATOC (TATE) or 131I-MIBG therapy for&#xD;
             this malignancy.&#xD;
&#xD;
          6. Another investigational drug within 4 weeks of study drug administration.&#xD;
&#xD;
          7. Concurrent, malignant disease for which patient is on active therapy.&#xD;
&#xD;
          8. Another significant medical, psychiatric, or surgical condition which is currently&#xD;
             uncontrolled by treatment and which would likely affect the subject's ability to&#xD;
             complete this protocol.&#xD;
&#xD;
          9. Any subject for whom, in the opinion of their physician, a 12-hour discontinuation of&#xD;
             somatostatin analogue therapy represents a health risk. Also subjects who have&#xD;
             received SandostatinLAR in the past 28 days or long-acting lanreotide within the past&#xD;
             8 weeks are excluded. Subjects may be maintained on short acting octreotide during the&#xD;
             time from last injection of long-acting somatostatin analogue until 12 hrs prior to&#xD;
             injection of study drug. Known antibodies to Octreotide, Lanreotide, or DOTATOC or&#xD;
             history of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to 90Y-DOTATOC.&#xD;
&#xD;
         10. Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or&#xD;
             mitomycin C) of study drug administration or those who have not recovered from adverse&#xD;
             events due to agents administered more than 4 weeks earlier.&#xD;
&#xD;
         11. Uncontrolled illness including, but not limited to ongoing or active infection,&#xD;
             symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or&#xD;
             psychiatric illness/social situations that would limit compliance with study&#xD;
             requirements.&#xD;
&#xD;
         12. Subject weighs more than 450 pounds. (Subjects who weigh more than 450 pounds will not&#xD;
             be able to fit inside the imaging machines.)&#xD;
&#xD;
         13. Inability to lie still for the entire imaging time (due to cough, severe arthritis,&#xD;
             etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>M. Sue O'Dorisio, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <results_first_submitted>November 19, 2022</results_first_submitted>
  <results_first_submitted_qc>February 6, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 9, 2023</results_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Sue O'Dorisio</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroblastoma</mesh_term>
    <mesh_term>Neuroendocrine Tumors</mesh_term>
    <mesh_term>Meningioma</mesh_term>
    <mesh_term>Medulloblastoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Octreotide</mesh_term>
    <mesh_term>Edotreotide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 19, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03273712/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 27, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03273712/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The University of Iowa Neuroendocrine Tumor Registry includes over 1500 individuals with NETs who have signed consent to be contacted when new clinical trials are available. The University of Iowa Children's Hospital has children with neuroblastoma and medulloblastoma (or other brain tumor) and neuroendocrine tumor who may be interested; in this case, participation would be offered only if/when the child failed conventional therapy.</recruitment_details>
      <pre_assignment_details>A subject can have the 90Y-DOTATOC treatment the next day after he/she signs the consent. Administration of 90Y-DOTATOC will likely be 12 hours to 1 month following confirmation of positive lesions on 68Ga-DOTATOC PET scan.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>90Y-DOTA-tyr3-Octreotide</title>
          <description>Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.&#xD;
90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.&#xD;
68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.&#xD;
Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>90Y-DOTA-tyr3-Octreotide</title>
          <description>Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.&#xD;
90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.&#xD;
68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.&#xD;
Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="39"/>
          </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="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54" lower_limit="9" upper_limit="79"/>
                  </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="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Frequency of Tumor Response at 9 Months After Last Treatment</title>
        <description>Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to quantify tumor response by comparison of baseline and last follow-up visit (6-9 months after last treatment) diagnostic CT/MRI scans.</description>
        <time_frame>Baseline through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>90Y-DOTA-tyr3-Octreotide</title>
            <description>Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.&#xD;
90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.&#xD;
68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.&#xD;
Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Tumor Response at 9 Months After Last Treatment</title>
          <description>Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to quantify tumor response by comparison of baseline and last follow-up visit (6-9 months after last treatment) diagnostic CT/MRI scans.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Complete Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Partial Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Stable Disease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Progressive Disease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Evaluable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Grade 4 or Higher Renal Adverse Event.</title>
        <description>The percentage of patients who experience a grade 4 or higher renal adverse event. Renal adverse events were graded using CTCAE v4.0 criteria.</description>
        <time_frame>Initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>90Y-DOTA-tyr3-Octreotide</title>
            <description>Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.&#xD;
90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.&#xD;
68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.&#xD;
Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Grade 4 or Higher Renal Adverse Event.</title>
          <description>The percentage of patients who experience a grade 4 or higher renal adverse event. Renal adverse events were graded using CTCAE v4.0 criteria.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Grade 4 or Higher Irreversible Adverse Events</title>
        <description>The percentage of patients who experience a grade 4 or higher irreversible adverse event. Adverse events were graded using CTCAE v4.0 criteria.</description>
        <time_frame>Initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>90Y-DOTA-tyr3-Octreotide</title>
            <description>Patients will receive 3 doses of 90YDOTATOC, with 6 -8 weeks between doses. They will be followed for 6 monthsafter the last treatment dose. CT or MRI scans will be given at the 3 month and 6 month followups. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.&#xD;
90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.&#xD;
Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Grade 4 or Higher Irreversible Adverse Events</title>
          <description>The percentage of patients who experience a grade 4 or higher irreversible adverse event. Adverse events were graded using CTCAE v4.0 criteria.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>90Y-DOTA-tyr3-Octreotide</title>
          <description>Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.&#xD;
90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.&#xD;
68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.&#xD;
Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE v4.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrine disorders - Other, specify</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Catheter related infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Infections and infestations - Other, specify</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal and urinary disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vascular disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE v4.0</default_vocab>
        <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="37" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Cardiac disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear and labyrinth disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrine disorders - Other, specify</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye disorders - Other, specify</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Gastroparesis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Hemorrhoidal hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="83" subjects_affected="37" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Oral dysesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="26" subjects_affected="15" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Edema face</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="20" subjects_affected="15" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Flu like symptoms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>General disorders and administration site conditions - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Infusion site extravasation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Localized edema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatobiliary disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchial infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Catheter related infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Infections and infestations - Other, specify</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Weight gain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" events="8" subjects_affected="4" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal and urinary disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Vascular disorders - Other, specify</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </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>M. Sue O'Dorisio, MD, PhD</name_or_title>
      <organization>University of Iowa</organization>
      <phone>(319) 335-7234</phone>
      <email>sue-odorisio@uiowa.edu</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/NCT03273712
org study id: 201708778
secondary id: R01CA167632
secondary id: 201412770
nct id: NCT03273712
nct alias: NCT02441088
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with
      somatostatin receptor positive tumors.
This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with
      somatostatin receptor positive tumors. The somatostatin receptor targeting of the therapeutic
      will be checked with 68Ga-DOTATOC PET-CT imaging prior to therapy. Treatment consists of 3
      cycles, 6-8 weeks apart. Cycle 1 dose is fixed with Cycles 2 and 3 doses to be determined by
      dosimetry-based calculation of renal doses from previous cycles not to exceed 23 Gy for the
      total renal dose.

      The goals of this project are to

        1. Demonstrate the safety and efficacy of dosimetry-guided peptide receptor radiotherapy
           using 90Y-DOTA-tyr3-Octreotide in patients with neuroendocrine and other somatostatin
           receptor expressing tumors.

        2. Monitor all adverse events associated with peptide receptor radiotherapy using
           90Y-DOTATOC.

        3. Establish 68Ga-DOTA-tyr3-Octreotide (68Ga-DOTATOC) or 68Ga-DOTATATE PET/CT as an
           accurate technique for diagnosis, staging, treatment targeting, and monitoring response
           to 90Y-DOTATOC therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Frequency of Tumor Response at 9 Months After Last Treatment
time frame: Baseline through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.
description: Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to quantify tumor response by comparison of baseline and last follow-up visit (6-9 months after last treatment) diagnostic CT/MRI scans.
measure: Percentage of Patients With Grade 4 or Higher Renal Adverse Event.
time frame: Initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.
description: The percentage of patients who experience a grade 4 or higher renal adverse event. Renal adverse events were graded using CTCAE v4.0 criteria.
measure: Percentage of Patients With Grade 4 or Higher Irreversible Adverse Events
time frame: Initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.
description: The percentage of patients who experience a grade 4 or higher irreversible adverse event. Adverse events were graded using CTCAE v4.0 criteria.
arm group label: 90Y-DOTA-tyr3-Octreotide
arm group type: Experimental
description: Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.
intervention type: Radiation
intervention name: 90Y-DOTA tyr3-Octreotide
description: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.
arm group label: 90Y-DOTA-tyr3-Octreotide
other name: 90Y-DOTATOC
intervention type: Diagnostic Test
intervention name: 68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan
description: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.
arm group label: 90Y-DOTA-tyr3-Octreotide
intervention type: Drug
intervention name: Amino Acids
description: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.
arm group label: 90Y-DOTA-tyr3-Octreotide
other name: Lysine and Arginine
criteria: 
gender: All
minimum age: 6 Months
maximum age: 90 Years
healthy volunteers: No
last name: M. Sue O'Dorisio, MD, PhD
role: Principal Investigator
affiliation: University of Iowa
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Iowa
investigator full name: Sue O'Dorisio
investigator title: Professor
mesh term: Neuroblastoma
mesh term: Neuroendocrine Tumors
mesh term: Meningioma
mesh term: Medulloblastoma
mesh term: Octreotide
mesh term: Edotreotide
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 