A clinical trial of the first phase of evaluating the safety and efficacy of the optimized intraperitoneal measles virus vaccine in patients with malignant ascites.
Use of optimized measles virus as a safe and effective method for improving malignant ascites
Design
The clinical trial has a control group, with parallel groups, without blinding, randomized, phase 1 on 20 patients. Using online randomization website.
Settings and conduct
This investigational study is going to be conduct in Baqiyatallah hospital. The patient will receive 5 cc of the liquid containing the optimized Measles vaccine intraperitoneal within standard treatments at the same time.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Confirmation of malignant pleural effusion
2- Over 18 years old
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 patient receives the optimized measles virus vaccine intraperitoneal while receiving standard treatments. The control group receives only standard treatments and does not receive the intraperitoneal treatment dose of the optimized measles virus vaccine.
A clinical trial of the first phase of evaluating the safety and efficacy of the optimized intraperitoneal measles virus vaccine in patients with malignant ascites.
Public title
Evaluation of the safety and efficacy of an optimized measles virus vaccine in patients with malignant ascites
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with malignant ascites
Patient age between 18 and 80 years
Absence of pregnancy
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
pregnancy
Using other investigational treatments at the same time
Age
From 18 years old to 80 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
20
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 20coincidences 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 in Research of the Educational and Therapeutic Center of Baqiyatullah Al-Azam
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
Examining changes in the patient's heart condition
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
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to standard treatment, patients receive the optimized measles vaccine product designed and optimized by Baqiyatallah University intraperitoneal. Simultaneously with treatment with the optimized measles vaccine, patients receive their standard treatments including chemotherapy and immunotherapy. In fact, the intervention is in the form of adjuvant therapy.