<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/NCT03015701</url>
  </required_header>
  <id_info>
    <org_study_id>SWOG-9005</org_study_id>
    <secondary_id>U10CA032102</secondary_id>
    <nct_id>NCT03015701</nct_id>
  </id_info>
  <brief_title>S9005 Mifepristone in Meningioma</brief_title>
  <official_title>Double Blind Randomized Trial of the Anti-Progestational Agent Mifepristone In The Treatment of Unresectable Meningioma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SWOG Cancer Research Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>SWOG Cancer Research Network</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare daily oral mifepristone vs placebo with respect to time to treatment failure in&#xD;
      patients with unresectable meningioma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To compare daily oral mifepristone vs placebo with respect to time to treatment failure in&#xD;
      patients with unresectable meningioma and to address issues of safety in this patient&#xD;
      population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 1992</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">October 2001</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Treatment Failure</measure>
    <time_frame>6 years</time_frame>
    <description>From date of registration to first date of documentation of one of the following:&#xD;
Progression (clear worsening of evaluable disease must be confirmed by 2 investigators).&#xD;
Significant deterioration of at least one neurologic symptom&#xD;
Discontinuation of treatment for any reason.&#xD;
Death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>two years after beginning treatment</time_frame>
    <description>Patients will be followed for adverse events as defined by the SWOG toxicity criteria</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">193</enrollment>
  <condition>Meningioma</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mifepristone 200 mg orally daily for two years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo orally daily for two years</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mifepristone</intervention_name>
    <description>a 19 norsteroid with anti-progesterone and anti glucocorticoid activity which competitively inhibits binding of the hormone to its receptor</description>
    <arm_group_label>Arm 1</arm_group_label>
    <other_name>RU-486</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo matching mifepristone</description>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must have a histologically documented primary, recurrent or residual&#xD;
             meningioma which is unresectable.&#xD;
&#xD;
          2. Patients must have active meningioma, which is defined to be one of the following:&#xD;
&#xD;
               1. Progressive disease within the past 2 years.&#xD;
&#xD;
               2. Recurrent Disease, as defined by the reappearance of a previously completely&#xD;
                  resected meningioma, within the past two years.&#xD;
&#xD;
               3. New disease, defined as a diagnosis of meningioma within the previous two years&#xD;
&#xD;
          3. Patients must have measurable or evaluable disease which is documented on CT or MRI&#xD;
             scan.&#xD;
&#xD;
          4. Patients should have already received radiotherapy unless radiotherapy is&#xD;
             inappropriate due to tumor location(s) or unless radiotherapy, after discussion with&#xD;
             the patient's physician, has been refused. If patients have received prior&#xD;
             radiotherapy, this treatment must have been completed more than one year prior to&#xD;
             study entry with documented progressive disease since completion of radiotherapy.&#xD;
&#xD;
          5. Patients must be 18 years or older, and must have a performance status 0-2 by&#xD;
             Southwest Oncology Group criteria.&#xD;
&#xD;
          6. Patients must not have received prior cytotoxic chemotherapy for meningioma.&#xD;
&#xD;
          7. Patients must have serum creatinine, SGOT, and bilirubin ≤ 2 x IULN.&#xD;
&#xD;
          8. Patients requiring simultaneous administration of corticosteroids for cerebral edema&#xD;
             must have been receiving a stable dose of corticosteroids for at least 4 weeks prior&#xD;
             to study entry.&#xD;
&#xD;
          9. Patients receiving anti-epileptic medications are eligible. However barbiturates&#xD;
             should be avoided if possible.&#xD;
&#xD;
         10. Patients with meningiomatosis (diffuse meningeal infiltration resulting in only&#xD;
             nonevaluable meningeal thickening) are not eligible. However, patients with multiple&#xD;
             measurable or evaluable meningioma tumor masses are eligible.&#xD;
&#xD;
         11. Patients with malignant meningioma are not eligible. Malignant meningioma is defined&#xD;
             as meningioma that demonstrates hypercellularity, loss of architecture, nuclear&#xD;
             pleomorphism, numerous mitoses, focal necrosis, and brain invasion.&#xD;
&#xD;
         12. Patients who have had additive or ablative modulation of sex hormone or glucocorticoid&#xD;
             pathways within the preceding 3 months (not including stable corticosteroid therapy&#xD;
             for cerebral edema) are not eligible. Such modulations include but are not limited to&#xD;
             birth control pills, bilateral oophorectomy or orchiectomy, progestational inserts,&#xD;
             oral or vaginal exogenous estrogens, androgens or antiandrogens, progestational&#xD;
             agonists, tamoxifen, aminoglutethimide, o,p-DDD, ACTH, glucocorticoids not for&#xD;
             cerebral edema, and leuprolides (or other LH-RH inhibitors). Patients must not have&#xD;
             received prior mifepristone therapy for meningioma.&#xD;
&#xD;
         13. Patients must not have serious intercurrent medical illness; that is, any illness that&#xD;
             in the opinion of the investigator would prevent following the study regimen.&#xD;
&#xD;
         14. Patients with clinical adrenal insufficiency requiring exogenous corticosteroid&#xD;
             replacement are not eligible.&#xD;
&#xD;
         15. Patients with a known allergy to mifepristone are not eligible.&#xD;
&#xD;
         16. Patients with base of brain, cavernous sinus or optic nerve meningiomas or with visual&#xD;
             symptoms must have a formal visual field examination.&#xD;
&#xD;
         17. Pregnant or lactating women may not participate. Pre-menopausal women and men of&#xD;
             reproductive potential may not participate unless they have agreed to use an effective&#xD;
             local contraceptive method (such as a condom, diaphragm, or IUD) or abstinence during&#xD;
             and for 3 months after study therapy.&#xD;
&#xD;
         18. Patients with other prior or concurrent malignancy within the preceding 5 years,&#xD;
             except surgically treated squamous or basal cell skin cancer or cervical cancer in&#xD;
             situ, are not eligible.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Blanke, MD</last_name>
    <role>Study Director</role>
    <affiliation>Oregon Health and Sciences University</affiliation>
  </overall_official>
  <link>
    <url>https://nctn-data-archive.nci.nih.gov/</url>
    <description>Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.</description>
  </link>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>December 19, 2019</last_update_submitted>
  <last_update_submitted_qc>December 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Unresectable</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningioma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mifepristone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>https://swog.org/Visitors/Download/Policies/Policy43.pdf</ipd_description>
  </patient_data>
  <!-- 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/NCT03015701
org study id: SWOG-9005
secondary id: U10CA032102
nct id: NCT03015701
lead sponsor: 
collaborator: 
has dmc: Yes
To compare daily oral mifepristone vs placebo with respect to time to treatment failure in
      patients with unresectable meningioma.
To compare daily oral mifepristone vs placebo with respect to time to treatment failure in
      patients with unresectable meningioma and to address issues of safety in this patient
      population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time to Treatment Failure
time frame: 6 years
description: From date of registration to first date of documentation of one of the following:
Progression (clear worsening of evaluable disease must be confirmed by 2 investigators).
Significant deterioration of at least one neurologic symptom
Discontinuation of treatment for any reason.
Death from any cause.
measure: Incidence of Treatment-Emergent Adverse Events
time frame: two years after beginning treatment
description: Patients will be followed for adverse events as defined by the SWOG toxicity criteria
arm group label: Arm 1
arm group type: Experimental
description: Mifepristone 200 mg orally daily for two years
arm group label: Arm 2
arm group type: Placebo Comparator
description: Placebo orally daily for two years
intervention type: Drug
intervention name: Mifepristone
description: a 19 norsteroid with anti-progesterone and anti glucocorticoid activity which competitively inhibits binding of the hormone to its receptor
arm group label: Arm 1
other name: RU-486
intervention type: Other
intervention name: Placebo
description: placebo matching mifepristone
arm group label: Arm 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
last name: Charles Blanke, MD
role: Study Director
affiliation: Oregon Health and Sciences University
url: https://nctn-data-archive.nci.nih.gov/
description: Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.
responsible party type: Sponsor
mesh term: Meningioma
mesh term: Mifepristone
sharing ipd: Yes
ipd description: https://swog.org/Visitors/Download/Policies/Policy43.pdf