The main goal of this study is to present a safe and powerful method along with other effective treatment methods in bladder tumor control.
Design
The clinical trial has a control group, with parallel groups, without blinding, randomized, phase 1 on 10 patients. Excel software was used for randomization.
Settings and conduct
The procedure is like inoculating the BCG vaccine into the bladder. One week after the inoculation of the last previous treatment, 50 cc of the liquid containing the optimized measles vaccine is inoculated intravesically.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Bladder cancer has been confirmed.
•The patient should be diagnosed by a urologist as a case who is resistant to BCG therapy
•Not possible to perform other treatments for bladder tumor for the patient.
•Age must be between 18 and 70
•not be pregnant.
•Karnofsky performance score of the patient should be more than 50%.
•Ability to understand and sign the consent form
•Liver, kidney and bone marrow functions should be appropriate.
•Liver enzymes should not be less than 2 times
•Willingness to comply with all required protocol steps,
•Must be willing to use contraceptive methods during the study
Exit criteria:
•Severe infection
•History of not following the doctor's treatment orders
•Sensitivity to vaccines
•Immune system defect
•Other investigational treatments
•Pregnancy
•Allergy to vaccine
•Organ transplantation
Intervention groups
After receiving the standard treatments, the intervention group will receive 4 intravesical doses of the measles virus vaccine with an interval of one week.
The control group received only their usual treatments and did not receive the intravesical dose of the optimized measles virus vaccine.
Main outcome variables
Weight- fever- heartburn Bleeding- pain in the abdominal area = nausea- frequent urination- blood factors- liver enzymes- changes in bladder tumors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230903059342N1
Registration date:2023-10-17, 1402/07/25
Registration timing:registered_while_recruiting
Last update:2023-10-17, 1402/07/25
Update count:0
Registration date
2023-10-17, 1402/07/25
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
2023-09-23, 1402/07/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Phase 1 clinical trials of Trial of Intravesical Measles Virotherapy in Patients With Bladder Cancer
Public title
Investigation of the safety and efficacy of the optimized measles virus vaccine in bladder tumor healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Bladder Cancer has been confirmed.
The patient should be diagnosed by a urologist.
It is not possible to remove the bladder for the patient.
The age of the patient must be above 18 years
The patient should not be pregnant.
The patient's Karnofsky performance score (KPS) should be 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 including the patient and one of these cases: the patient's spouse, parent.
Ability to provide informed consent
Be willing to comply with all required protocol steps, including providing biological samples and returning to the clinical study site for subsequent visits.
Adequate performance status for treatment in the opinion of the enrolling urologist, including adequate hematological, liver, and renal function
Must be willing to use contraceptive methods during the study.
Exclusion criteria:
Severe or life-threatening acute infection
A history of not following the doctor's treatment orders
Use of drugs that weaken the immune system
Having diseases that disrupt the immune system
History of organ transplantation
Allergy to measles vaccine
pregnancy
Concomitant use of other investigational treatments
Disease to other cancers such as skin that have not been fully treated.
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
In this study, simple randomization is used so that the referents who have the conditions to enter the study are asked to choose between the numbers 1 and 2. If he chooses number 1, he enters the control group, and if he chooses number 2, he enters the new treatment group.
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
FARHIKHTEGAN Hospital- Islamic Azad University
Street address
Tehran, at the end of Sattari, north of University Square, in front of the Central Organization
City
Tehran
Province
Tehran
Postal code
1477899679
Approval date
2023-08-15, 1402/05/24
Ethics committee reference number
IR.IAU.FARHIKHTEGANH.REC.1402.005
Health conditions studied
1
Description of health condition studied
Bladder Cancer
ICD-10 code
C67
ICD-10 code description
Malignant neoplasm of bladder
Primary outcomes
1
Description
Re-observation of bladder tumor by cystoscopy
Timepoint
Three months
Method of measurement
Cystoscopy examination of the bladder
Secondary outcomes
empty
Intervention groups
1
Description
They include patients who receive the optimized measles vaccine product in addition to the standard treatment.
Category
Treatment - Other
2
Description
Control group: Patients who receive only standard treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farhikhtegan Hospital
Full name of responsible person
Dr. Mohammad Soleimani
Street address
North Sattari، Islamic Azad Univesity Square، Tehran، Iran
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4484 5163
Email
farhikhteganhospital@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kian Gen Azma Company
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
Kian Gen Azma Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
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
1619748194
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
1619748194
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
1619748194
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