<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20230903059342N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-11-11</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of Neuroblastoma cancer treatment by optimized measles vaccine</public_title>
      <acronym></acronym>
      <scientific_title>The first phase and second of the trial investigating the safety and efficacy of Intratumorally optimized measles vaccine in patients with Neuroblastoma cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/87327</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is going to be done by the method of random blocks of 6 random strings with a length of 15 coincidences with a ratio of 2 to 1.
This string is created by one of the online randomization software.
In order to hide the randomization, the method of closed envelopes will be used.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Neuroblastoma Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: includes patients who, in addition to standard treatment, receive the optimized measles vaccine  intraperitoneally in 2 doses 4 weeks apart. At the same time as being treated with the optimized measles vaccine, the patient receives standard treatments including chemotherapy and immunotherapy. In fact, the intervention is in the form of adjuvant therapy. Intervention 2: Control group: They receive only standard treatment including chemotherapy and immunotherapy and no intervention is done in their standard treatment.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ruhollah Dorostkar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Virology Lab. Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahai South Avenue, Mollasadra St, Vanak Sq, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8817 0179</telephone>
        <email>R.dorost@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ruhollah Dorostkar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Virology Lab. Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahai South Avenue, Mollasadra St, Vanak Sq, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8817 0179</telephone>
        <email>R.dorost@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient age 2 to 21
The patient must be considered by a pediatric oncologist to be refractory to conventional treatments or for which there is no standard treatment.
The non-central nervous system solid tumor has been confirmed by a histologist.
Proper functioning of liver, kidney and bone marrow
The ability to understand and sign the consent form by the patient and one of these cases: the patient's spouse, parent or guardian.
Complying with all protocol steps including sample submission and returning to the clinical study site for subsequent visits
Absence of autoimmune diseases or diseases of the immune system</inclusion_criteria>
      <agemin>2 years</agemin>
      <agemax>21 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Life-threatening acute infection
Absence of any previous record that describes the doctor's treatment and orders were nor followed by patient.
Using drugs that weaken the immune system
Affected by any diseases that disturbs the immune system
Having any previous record of organ transplantation
Allergy to measles vaccine
Using other investigational treatments at the same time</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C47</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of peripheral nerves and autonomic nervous system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: includes patients who, in addition to standard treatment, receive the optimized measles vaccine  intraperitoneally in 2 doses 4 weeks apart. At the same time as being treated with the optimized measles vaccine, the patient receives standard treatments including chemotherapy and immunotherapy. In fact, the intervention is in the form of adjuvant therapy.</i_keyword>
      <i_keyword>Control group: They receive only standard treatment including chemotherapy and immunotherapy and no intervention is done in their standard treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fever. Timepoint: Hourly in the first 24 hours and then daily up to 7 days. Method of measurement: Thermometer.</prim_outcome>
      <prim_outcome>Examining changes in the patient's heart condition. Timepoint: Hourly after the start of treatment for up to 7 days. Method of measurement: Electrocardiogram.</prim_outcome>
      <prim_outcome>Examining changes in the patient's breathing status. Timepoint: Hourly in the first 24 hours and then daily up to 7 days. Method of measurement: pulse oximeter.</prim_outcome>
      <prim_outcome>Examination of tumor size. Timepoint: Weekly until 6 months after the end of treatment. Method of measurement: Sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-10-27</approval_date>
        <contact_name>Ethics committee of Baqiyatallah University of Medical Sciences</contact_name>
        <contact_address>mollasadra st, vanak sq sheykh bahayi st,Tehran,Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
