The first phase and second of the trial investigating the safety and efficacy of Intratumorally optimized measles vaccine in patients with Neuroblastoma cancer
Using optimized measles virus as a safe and effective method along other treatment methods to control the Neuroblastoma tumor
Design
The clinical trial has a control group, with parallel groups, without blinding, randomized, phase 1and 2 on 10patients. Using online randomization website.
Settings and conduct
This investigational study is going to be conduct in Shahid Sadoughi Hospital, Yazd and Baqiyatallah Hospital. The patient will receive 2 cc of the liquid containing the optimized Measles vaccine intratumorally within standard treatments at the same time.
Participants/Inclusion and exclusion criteria
Ovarian cancer confirmed as treatment-resistant by Pediatric cancer specialist 2-Age between 2 and 21 years . 3-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 2 doses of the optimized measles virus vaccine intratumorally 4 weeks apart. Control group will receive only the standard treatments and will not receive the the optimized measles virus vaccine intratumorally.
Main outcome variables
Fever, pain in the abdominal area, nausea, blood factors, liver enzymes and tumor size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230903059342N4
Registration date:2025-11-11, 1404/08/20
Registration timing:prospective
Last update:2025-11-11, 1404/08/20
Update count:0
Registration date
2025-11-11, 1404/08/20
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
recruiting
Funding source
Expected recruitment start date
2025-11-22, 1404/09/01
Expected recruitment end date
2027-11-22, 1406/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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
Public title
Evaluation of Neuroblastoma cancer treatment by optimized measles vaccine
Purpose
Treatment
Inclusion/Exclusion 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
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
Age
From 2 years old to 21 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
10
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
Malignant neoplasm of peripheral nerves and autonomic nervous system
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
Examination of tumor size
Timepoint
Weekly until 6 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 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.
Category
Treatment - Other
2
Description
Control group: They receive only standard treatment including chemotherapy and immunotherapy and no intervention is done in their standard treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Dr Hassan Abolghasemi
Street address
Tehran, Molla Sadra Street, the intersection of South Sheikh Bahai Street