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Investigation of the safety and efficacy of the optimized measles virus vaccine in bladder tumor healing

Phase 1
Recruiting
Conditions
Bladder Cancer.
Malignant neoplasm of bladder
Registration Number
IRCT20230903059342N1
Lead Sponsor
Kian Gen Azma Company
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
10
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.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Re-observation of bladder tumor by cystoscopy. Timepoint: Three months. Method of measurement: Cystoscopy examination of the bladder.
Secondary Outcome Measures
NameTimeMethod
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