<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/NCT02184533</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-30587</org_study_id>
    <secondary_id>NCI-2014-01361</secondary_id>
    <secondary_id>PROS0047</secondary_id>
    <secondary_id>P30CA124435</secondary_id>
    <nct_id>NCT02184533</nct_id>
  </id_info>
  <brief_title>Sodium Selenite and Radiation Therapy in Treating Patients With Metastatic Cancer</brief_title>
  <official_title>A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Palliative Radiation Therapy in Patients With Metastatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Susan Knox</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</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>
      The purpose of this study is to determine the maximum-tolerated dose (MTD) of sodium selenite&#xD;
      when administered in combination with radiation therapy to subjects with metastatic cancer&#xD;
      based on safety and tolerability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objectives:&#xD;
&#xD;
        -  To determine the maximum tolerated dose (MTD) of sodium selenite when given in&#xD;
           combination with palliative radiation therapy&#xD;
&#xD;
        -  To assess the safety and tolerability of the combination of sodium selenite and&#xD;
           palliative radiation therapy in metastatic cancer&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To assess the pharmacokinetics of sodium selenite&#xD;
&#xD;
        -  To evaluate the anti tumor activity of sodium selenite and palliative radiation therapy&#xD;
           when given in combination&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive sodium selenite orally (PO) 2 hours before daily radiation therapy&#xD;
      treatments. Treatment continues for the duration of the course of radiation therapy in the&#xD;
      absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 2 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</primary_completion_date>
  <phase>Phase 1</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>MTD defined as the maximum dose at which =&lt; 1 of 3 to 6 subjects in a dose group experience a drug-related dose-limiting toxicity, graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version (v)4.0</measure>
    <time_frame>3 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability of the combination using the NCI Common Toxicity Criteria v4.0 grading system for adverse events</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Safety observations and measurements including adverse events, laboratory data, vital signs, and performance status will be summarized.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic (PK) profile</measure>
    <time_frame>Week 1, day 1: at predose; 15 minutes; and at 1, 2, 4, and 24 hours; weeks 2 and 4, day 1: at predose and 1 hour</time_frame>
    <description>PK parameters will be calculated using non-compartmental and/or compartmental models and PK parameters (if possible, maximum concentration [Cmax], time to Cmax, area under the curve during the dosing interval, half-life, oral clearance) will be summarized and presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall biochemical response rate</measure>
    <time_frame>Up to 11 weeks</time_frame>
    <description>Biochemical response defined as PSA decline &gt;= 50% from baseline at 8 weeks of therapy and which has been confirmed with a second PSA at &gt;= 3 weeks later.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor responses within the radiation therapy field, assessed using Response Evaluation Criteria in Solid Tumors 1.1</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate (complete response, partial response and stable disease) within the radiation therapy field</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Adenocarcinoma of the Prostate</condition>
  <condition>Hormone-resistant Prostate Cancer</condition>
  <condition>Recurrent Prostate Cancer</condition>
  <condition>Stage IV Prostate Cancer</condition>
  <condition>Multiple Myeloma</condition>
  <condition>Plasmacytoma</condition>
  <arm_group>
    <arm_group_label>Treatment (sodium selenite and radiation therapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive sodium selenite PO 2 hours before daily radiation therapy treatments. Treatment continues for the duration of the course of radiation therapy in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sodium selenite</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (sodium selenite and radiation therapy)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>radiation therapy</intervention_name>
    <description>Undergo radiation therapy</description>
    <arm_group_label>Treatment (sodium selenite and radiation therapy)</arm_group_label>
    <other_name>irradiation</other_name>
    <other_name>radiotherapy</other_name>
    <other_name>therapy, radiation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (sodium selenite and radiation therapy)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pharmacological study</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (sodium selenite and radiation therapy)</arm_group_label>
    <other_name>pharmacological studies</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Treatment (sodium selenite and radiation therapy)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Histologically confirmed adenocarcinoma of the prostate from a prostate biopsy or&#xD;
             prostatectomy specimen (primary site), or histological confirmation of adenocarcinoma&#xD;
             /carcinoma in a metastatic site of disease in the setting of elevated PSA and imaging&#xD;
             consistent with metastatic prostate cancer, or history of prostate cancer with&#xD;
             documented metastasis, or histologically confirmed other solid tumor malignancy,&#xD;
             multiple myeloma, or plasmacytoma with pathological confirmation of metastasis&#xD;
&#xD;
          2. Metastatic cancer requiring palliative radiation therapy&#xD;
&#xD;
          3. For patients with metastatic prostate cancer, PSA ≥ 2 ng/mL, except for patients who&#xD;
             have recently started androgen deprivation therapy with PSA &lt; 2 ng/mL&#xD;
&#xD;
          4. Age ≥18 years&#xD;
&#xD;
          5. Life expectancy greater than 3 months&#xD;
&#xD;
          6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or Karnofsky&#xD;
             performance status ≥ 80%&#xD;
&#xD;
          7. QT interval corrected using Fridericia's method (QTcF) &lt; 460 msec (see Appendix C for&#xD;
             Fredericia's criteria).&#xD;
&#xD;
          8. Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Inadequate organ function, as evidenced by any of the following at screening:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) &lt; 1500/µL&#xD;
&#xD;
               -  Platelet count ≤ 100 x 109/L&#xD;
&#xD;
               -  Serum creatinine &gt; 2.0 mg/dL&#xD;
&#xD;
               -  Total bilirubin &gt; 1.5 x upper limit of normal (ULN)&#xD;
&#xD;
               -  AST, and/or ALT &gt; 2 x ULN&#xD;
&#xD;
               -  Hemoglobin &lt; 9 g/dL&#xD;
&#xD;
          2. Men with reproductive potential who do not agree to use an accepted and effective&#xD;
             method of contraception during the study treatment period and for at least 3 months&#xD;
             after completion of the study treatment&#xD;
&#xD;
          3. History of other malignancies within 5 years prior to Day 1 except for tumors that in&#xD;
             the opinion of the investigators have a negligible risk for metastasis or death, such&#xD;
             as (but not exclusively) adequately controlled basal cell carcinoma, squamous cell&#xD;
             carcinoma of the skin, or early stage bladder cancer&#xD;
&#xD;
          4. Current, or recent (within 4 weeks of the first treatment of this study) cytotoxic&#xD;
             chemotherapy (eg, cisplatin, taxol) or experimental drug therapy, or planned&#xD;
             participation in an experimental drug study&#xD;
&#xD;
          5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, significant vascular disease (eg, aortic aneurysm, aortic dissection),&#xD;
             symptomatic peripheral vascular disease, or psychiatric illness/social situations that&#xD;
             would limit compliance with study requirements&#xD;
&#xD;
          6. History of myocardial infarction or unstable angina within 6 months prior to study&#xD;
             enrollment&#xD;
&#xD;
          7. History of stroke or transient ischemic attack within 6 months prior to study&#xD;
             enrollment&#xD;
&#xD;
          8. The subject is known to be positive for the human immunodeficiency virus (HIV) and is&#xD;
             receiving antiretroviral therapies. Subjects known to be HIV positive who do not&#xD;
             require antiretroviral therapy will be eligible if they meet other entry criteria&#xD;
&#xD;
          9. Women who are pregnant or breastfeeding&#xD;
&#xD;
         10. Inability to comply with study and/or follow up procedures&#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>Susan Knox</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University Hospitals and Clinics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University, School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>February 14, 2020</last_update_submitted>
  <last_update_submitted_qc>February 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Susan Knox</investigator_full_name>
    <investigator_title>Associate Professor of Radiation Oncology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Plasmacytoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Selenious Acid</mesh_term>
    <mesh_term>Sodium Selenite</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <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>April 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT02184533/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02184533
org study id: IRB-30587
secondary id: NCI-2014-01361
secondary id: PROS0047
secondary id: P30CA124435
nct id: NCT02184533
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine the maximum-tolerated dose (MTD) of sodium selenite
      when administered in combination with radiation therapy to subjects with metastatic cancer
      based on safety and tolerability.
Primary Objectives:

        -  To determine the maximum tolerated dose (MTD) of sodium selenite when given in
           combination with palliative radiation therapy

        -  To assess the safety and tolerability of the combination of sodium selenite and
           palliative radiation therapy in metastatic cancer

      Secondary Objectives:

        -  To assess the pharmacokinetics of sodium selenite

        -  To evaluate the anti tumor activity of sodium selenite and palliative radiation therapy
           when given in combination

      OUTLINE:

      Patients receive sodium selenite orally (PO) 2 hours before daily radiation therapy
      treatments. Treatment continues for the duration of the course of radiation therapy in the
      absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 2 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MTD defined as the maximum dose at which =< 1 of 3 to 6 subjects in a dose group experience a drug-related dose-limiting toxicity, graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version (v)4.0
time frame: 3 weeks
measure: Safety and tolerability of the combination using the NCI Common Toxicity Criteria v4.0 grading system for adverse events
time frame: Up to 2 years
description: Safety observations and measurements including adverse events, laboratory data, vital signs, and performance status will be summarized.
measure: Pharmacokinetic (PK) profile
time frame: Week 1, day 1: at predose; 15 minutes; and at 1, 2, 4, and 24 hours; weeks 2 and 4, day 1: at predose and 1 hour
description: PK parameters will be calculated using non-compartmental and/or compartmental models and PK parameters (if possible, maximum concentration [Cmax], time to Cmax, area under the curve during the dosing interval, half-life, oral clearance) will be summarized and presented.
measure: Overall biochemical response rate
time frame: Up to 11 weeks
description: Biochemical response defined as PSA decline >= 50% from baseline at 8 weeks of therapy and which has been confirmed with a second PSA at >= 3 weeks later.
measure: Tumor responses within the radiation therapy field, assessed using Response Evaluation Criteria in Solid Tumors 1.1
time frame: Up to 2 years
measure: Response rate (complete response, partial response and stable disease) within the radiation therapy field
time frame: Up to 2 years
arm group label: Treatment (sodium selenite and radiation therapy)
arm group type: Experimental
description: Patients receive sodium selenite PO 2 hours before daily radiation therapy treatments. Treatment continues for the duration of the course of radiation therapy in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: sodium selenite
description: Given PO
arm group label: Treatment (sodium selenite and radiation therapy)
intervention type: Radiation
intervention name: radiation therapy
description: Undergo radiation therapy
arm group label: Treatment (sodium selenite and radiation therapy)
other name: irradiation
other name: radiotherapy
other name: therapy, radiation
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Treatment (sodium selenite and radiation therapy)
intervention type: Other
intervention name: pharmacological study
description: Correlative studies
arm group label: Treatment (sodium selenite and radiation therapy)
other name: pharmacological studies
intervention type: Other
intervention name: questionnaire administration
description: Ancillary studies
arm group label: Treatment (sodium selenite and radiation therapy)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susan Knox
role: Principal Investigator
affiliation: Stanford University Hospitals and Clinics
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Stanford University
investigator full name: Susan Knox
investigator title: Associate Professor of Radiation Oncology
mesh term: Prostatic Neoplasms
mesh term: Multiple Myeloma
mesh term: Neoplasm Metastasis
mesh term: Plasmacytoma
mesh term: Selenious Acid
mesh term: Sodium Selenite
sharing ipd: No
provided document: 