Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis

NCT03982797 | Unknown Phase 2 DMC

• 2 other identifiers: ENCORE-012017-002928-24
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 15

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.

Conditions

Bladder Cancer

Keywords

non-muscle invasive bladder tumors

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  The primary objective is to assessment the progression-free survival of patients diagnosed with high-risk non-muscle invasive bladder tumors treated with IMUNO BCG Moreau RJ adjuvant.

  24 months

Secondary Outcomes (4)

• Disease-free survival.

  24 months

• Assessment of the quality of life

  24 months

• Assessment of adverse reactions

  24 months

• Assessment of the dropout rate due to toxicity

  24 months

Study Arms (1)

treated with IMUNO BCG Moreau RJ adjuvant.

EXPERIMENTAL

Biological: Instillation of IMUNO BCG Moreau RJ

Interventions

Instillation of IMUNO BCG Moreau RJ BIOLOGICAL

Instillation in bladder will be done once per week during first six weeks after inclusion, and 3 instillations (one per week) on month three, another three on moth six and last three on month twelve .

treated with IMUNO BCG Moreau RJ adjuvant.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signature of the informed consent before any activity related to the study, including the necessary evaluations for the selection.
• Age between 18 and 80 years at the time of signing the informed consent.
• Urothelial tumor.
• 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.
• Patient with risk of recurrence or progression greater than or equal to 10 points, according to CUETO tables.

You may not qualify if:

• No muscle layer in pathological examination piece's.
• Non-urothelial tumor.
• Active cancer in any other location.
• 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.
• 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.
• \. Impossibility of performing a second transurethral resection (ReRTU) between 4 and 8 weeks after the first.
• \. Inability to start treatment within the first 4 weeks after the second transurethral resection (ReRTU).
• \. Participation in another clinical study where they received a research drug in the 6 months prior to signing the informed consent.
• \. 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.
• \. Patients with difficulties to perform the follow-up visits established in the protocol.

Sponsors & Collaborators

• Biofabri, S.L: lead
• Fundación para la Investigación en Urología (FIU): collaborator

Study Sites (15)

Complexo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

NOT YET RECRUITING

Hospital Universitario Basurto

Bilbao, 48013, Spain

ACTIVE NOT RECRUITING

Complejo Hospitalario Puerta Del Mar

Cadiz, 11009, Spain

ACTIVE NOT RECRUITING

Complejo Hospitalario Regional Reina Sofía

Córdoba, 14004, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Virgen de Las Nieves

Granada, 18014, Spain

RECRUITING

Complejo Hospitalario Médico Quirúrjico de Jaén

Jaén, 23007, Spain

ACTIVE NOT RECRUITING

Hospital de Especialidades de Jerez de La Frontera

Jerez de la Frontera, 11408, Spain

ACTIVE NOT RECRUITING

Hospital Fundacion Jimenez Diaz

Madrid, 28040, Spain

ACTIVE NOT RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

ACTIVE NOT RECRUITING

Complejo Universitario La Paz

Madrid, 28046, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, 28222, Spain

NOT YET RECRUITING

Complejo Hospitalario Regional de Málaga

Málaga, 29010, Spain

NOT YET RECRUITING

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

NOT YET RECRUITING

Clinica Universidad de Navarra

Pamplona, 31008, Spain

NOT YET RECRUITING

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Miguel Unda, MD

  Hospital Universitario Basurto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingrid Murillo, MSc.

CONTACT

0034986330400; ingrid.murillo@biofabri.es

Sara Barja, MSc.

CONTACT

0034986330400; sara.barja@biofabri.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 12, 2019
• Study Start: May 17, 2019
• Primary Completion: April 3, 2021
• Study Completion: March 3, 2022
• Last Updated: June 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (15)