Evaluation of the Effect of Intrapleural Administration of an Optimized Measles Vaccine on Dyspnea Improvement and Effusion Volume in Patients with Malignant Pleural Effusion
Use of optimized measles virus as a safe and effective method in improving dyspnea and effusion volume in patients with malignant pleural effusion
Design
The clinical trial has a control group, with parallel groups, without blinding, randomized, phase 1 on 10 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 intratumorally 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 intrapleurally while receiving standard treatments. The control group receives only standard treatments and does not receive the intrapleural treatment dose of the optimized measles virus vaccine.
Evaluation of the Effect of Intrapleural Administration of an Optimized Measles Vaccine on Dyspnea Improvement and Effusion Volume in Patients with Malignant Pleural Effusion
Public title
Study of helping to improve shortness of breath and effusion volume in patients with malignant pleural effusion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with malignant pleural effusion
Patient age over 18 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
Gender
Both
Phase
1
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
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 intrapleurally. 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.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Abbas Samim
Street address
Tehran, Molla Sadra Street, the intersection of South Sheikh Bahai Street
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 85554
Email
R.dorost@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Ruhollah Dorostkar
Street address
North Suhravardi, lower than Dr. Shahid Beheshti St., Sink Alley, No. 20,
City
Tehran
Province
Tehran
Postal code
1577943613
Phone
+98 21 8817 0179
Email
R.dorost@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ruhollah Dorostkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Virology Lab. Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahai South Avenue, Mollasadra St, Vanak Sq, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8817 0179
Fax
Email
R.dorost@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ruhollah Dorostkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Virology Lab. Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahai South Avenue, Mollasadra St, Vanak Sq, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8817 0179
Fax
Email
R.dorost@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ruhollah Dorostkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Virology Lab. Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahai South Avenue, Mollasadra St, Vanak Sq, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8817 0179
Fax
Email
R.dorost@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available