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

NCT03982797 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2019-06-12

No results posted yet for this study

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

Interventions

BIOLOGICAL

Instillation of IMUNO BCG Moreau RJ

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 .

Sponsors & Collaborators

  • Fundación para la Investigación en Urología (FIU)

    collaborator UNKNOWN

  • Biofabri, S.L

    lead INDUSTRY

Principal Investigators

  • Miguel Unda, MD · Hospital Universitario Basurto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-17
Primary Completion
2021-04-03
Completion
2022-03-03

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03982797 on ClinicalTrials.gov