Using optimized measles virus as a safe and effective method along other treatment methods to control the ovarian tumor.
Design
The clinical trial has a control group, with parallel groups, without blinding, randomized, phase 1 on 15 patients. Using online randomization website.
Settings and conduct
This investigational study is going to be conduct in Baqiyatallah hospital. The process is similar to intraperitoneal chemotherapy. The patient will receive 100 cc of the liquid containing the optimized Measles vaccine intraperitoneally within standard treatments at the same time.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Ovarian cancer confirmed as treatment-resistant by gynecologist
2-Age between 18 and 70 years
3-Karnofsky performance score (KPS) more than 50% (the patient should not be disabled and should not need special assistance care).
4-The ability to understand and sign the consent form by patient or patients spouse, parent or guardian
Exclusion criteria:
1-Any difficulty in liver, kidney and bone marrows function.
2-Failure to cooperate in performing the required protocol, such as gathering samples and visiting for clinical study.
3-Any Infection, autoimmune disease or immune system weakness.
Intervention groups
The under care group will receive 4 doses of the optimized measles virus vaccine within two-week of time gap for each dose.they will receive only the standard treatments and will not receive the intraperitoneal dose of the optimized measles virus vaccine.
Main outcome variables
Fever and pain in the abdominal area and nausea blood factors and liver enzymes and changes in ca125 and abdominal tumors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230903059342N2
Registration date:2023-12-28, 1402/10/07
Registration timing:registered_while_recruiting
Last update:2023-12-28, 1402/10/07
Update count:0
Registration date
2023-12-28, 1402/10/07
Registrant information
Name
Ruhollah Dorostkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8817 0179
Email address
r.dorost@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Phase 1 Clinical Trials of Intraperitoneal Measles Virotherapy in Patients With Ovarian Cancer
Public title
Investigating the treatment of ovarian cancer by optimized measles vaccine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
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
pregnancy
Using other investigational treatments at the same time
Being effected by other cancers
Age
From 18 years old to 70 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahai South Avenue, Mollasadra St, Vanak Sq, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2023-11-29, 1402/09/08
Ethics committee reference number
IR.BMSU.REC.1402.070
Health conditions studied
1
Description of health condition studied
Ovarian cancer
ICD-10 code
C56
ICD-10 code description
Malignant neoplasm of ovary
Primary outcomes
1
Description
Fever
Timepoint
Hourly in the first 24 hours and then daily up to 7 days
Method of measurement
Thermometer
2
Description
Examining changes in the patient's heart condition
Timepoint
Hourly after the start of treatment for up to 7 days
Method of measurement
Electrocardiogram
3
Description
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
4
Description
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
5
Description
Examination of tumors of the abdominal cavity
Timepoint
Weekly until 3 months after the end of treatment
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
Control group: patients who receive only standard treatment including chemotherapy with Cisplatin and immunotherapy with Avastin