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IRCT20230903059342N2 IRCT 2023-12-28 Kian Gen Azma Company Investigating the treatment of ovarian cancer by optimized measles vaccine Phase 1 Clinical Trials of Intraperitoneal Measles Virotherapy in Patients With Ovarian Cancer 2023-12-22 anticipated 15 Complete https://irct.ir/trial/72668 interventional 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. 1 Ovarian cancer. Intervention 1: Intervention group: includes patients who, in addition to standard treatment, receive the optimized measles vaccine that designed and optimized by Baqiyatullah university intraperitoneally in four doses with an interval of two weeks for each dose. At the same time as being treated with the optimized measles vaccine, the patient receives standard treatments including chemotherapy with cisplatin and immunotherapy with Avastin. In fact, the intervention is in the form of adjuvant therapy. Intervention 2: Control group: patients who receive only standard treatment including chemotherapy with Cisplatin and immunotherapy with Avastin. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Ruhollah Dorostkar
Virology Lab. Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahai South Avenue, Mollasadra St, Vanak Sq, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8817 0179 R.dorost@yahoo.com Bagheiat-allah University of Medical Sciences scientific Seyedeh Razieh Hashemi
Baqiyatallah Hospital, Mollasadra Ave., Vanak Square ., Tehran, Iran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8805 0435 R.dorost@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Confirmation of the patient's ovarian cancer by a gynecologist Diagnosis of disease as drug resistance Patient age 18 to 70 Absence of pregnancy. The Karnofsky performance score (KPS) of the patient is more than 50% (the patient is not disabled and does not need special assistance and care). The ability to understand and sign the consent form by the patient and one of these cases: the patient's spouse, parent or guardian. Proper functioning of liver, kidney and bone marrow 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 18 years 70 years Female 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 pregnancy Using other investigational treatments at the same time Being effected by other cancers C56 Malignant neoplasm of ovary Treatment - Other Other Intervention group: includes patients who, in addition to standard treatment, receive the optimized measles vaccine that designed and optimized by Baqiyatullah university intraperitoneally in four doses with an interval of two weeks for each dose. At the same time as being treated with the optimized measles vaccine, the patient receives standard treatments including chemotherapy with cisplatin and immunotherapy with Avastin. In fact, the intervention is in the form of adjuvant therapy. Control group: patients who receive only standard treatment including chemotherapy with Cisplatin and immunotherapy with Avastin Fever. Timepoint: Hourly in the first 24 hours and then daily up to 7 days. Method of measurement: Thermometer. Examining changes in the patient's heart condition. Timepoint: Hourly after the start of treatment for up to 7 days. Method of measurement: Electrocardiogram. 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. Examining the amount of ca 125 cancer antigen in the blood. Timepoint: Weekly until 3 months after the end of treatment. Method of measurement: Blood test. Examination of tumors of the abdominal cavity. Timepoint: Weekly until 3 months after the end of treatment. Method of measurement: Sonography. Kian Gen Azma Company Approved 2023-11-29 Ethics committee of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahai South Avenue, Mollasadra St, Vanak Sq, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)