Clinical trial NCT03982797: Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis
Official title: Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis of Recurrence and Progression.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: non-muscle invasive bladder tumors
Lead sponsor: Biofabri, S.L
Sponsor class: INDUSTRY
Collaborators: name: Fundación para la Investigación en Urología (FIU)
First posted: 2019-06-12
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bladder cancer is the fourth reason of neoplasia in our environment, there are 25 new cases diagnosed per 100,000 inhabitants each year. To decrease the recurrence there are two standardized treatments: Mitomycin as chemotherapy drug and BCG \*Bacile Calmette-Guérin" as immunotherapy drug.

BCG Moreau strain is not authorized by AEMPS, it was developed in Brazil and this country has extensive experience in treatment of non-muscle invasive bladder cancer with BCG Moreau, also BCG Moreau Rio de Janeiro make same immunological reaction as TICE, but with less adverse events. Thus, BCG Moreau RJ treatment could be used more time than TICE with the same dose, keeping immunologic status and better prophylaxis of recurrence or progression results for the patient.

Each patient will be instillated via transurethral each time with 80 mg of IMUNO BCG Moreau RJ. There are 15 instillations during the clinical trial, 6 instillations on induction phase and 9 will be performed during maintaince phase.


Eligibility criteria: Inclusion Criteria:

1. Signature of the informed consent before any activity related to the study, including the necessary evaluations for the selection.
2. Age between 18 and 80 years at the time of signing the informed consent.
3. Urothelial tumor.
4. High risk non-muscle invasive bladder tumor (defined as Ta-T1 and GIIb or GIII) diagnosed de novo or relapsed with or without associated in situ carcinoma. or carcinoma in situ isolated without visible tumor.
5. Patient with risk of recurrence or progression greater than or equal to 10 points, according to CUETO tables.

Exclusion Criteria:

1. No muscle layer in pathological examination piece's.
2. Non-urothelial tumor.
3. Active cancer in any other location.
4. Diagnosis of any other pathology that in the opinion of the researcher may increase the risk of the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study, including the consumption of alcohol or any other drug.
5. Administration of BCG in the last year before signing the informed consent. 6. BCG instillation contraindication during more than 15 days for any cause such as low bladder capacity, urinary infection, hematuria, etc.

7. Impossibility of performing a second transurethral resection (ReRTU) between 4 and 8 weeks after the first.

8. Inability to start treatment within the first 4 weeks after the second transurethral resection (ReRTU).

9. Participation in another clinical study where they received a research drug in the 6 months prior to signing the informed consent.

10. Woman considered potentially fertile. Following the Clinical Trial Facilitation Group (CTFG) recommendations, a woman is considered childbearing potential (WOCBP), following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

11. Patients with difficulties to perform the follow-up visits established in the protocol.

Primary outcomes:
measure: progression-free survival
timeFrame: 24 months
Secondary outcomes:
measure: Disease-free survival.
timeFrame: 24 months
measure: Assessment of the quality of life
timeFrame: 24 months
measure: Assessment of adverse reactions
timeFrame: 24 months
measure: Assessment of the dropout rate due to toxicity
timeFrame: 24 months
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Hospital Universitario Basurto
city: Cadiz
country: Spain
facility: Complejo Hospitalario Puerta Del Mar
city: Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
city: Córdoba
country: Spain
facility: Complejo Hospitalario Regional Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Jaén
country: Spain
facility: Complejo Hospitalario Médico Quirúrjico de Jaén
city: Jerez de la Frontera
country: Spain
facility: Hospital de Especialidades de Jerez de La Frontera
city: Madrid
country: Spain
facility: Hospital Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Complejo Universitario La Paz
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Málaga
country: Spain
facility: Complejo Hospitalario Regional de Málaga
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
affiliation: Hospital Universitario Basurto
name: Miguel Unda, MD
role: PRINCIPAL_INVESTIGATOR
References: