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

Primary Purpose

Bladder Cancer

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Instillation of IMUNO BCG Moreau RJ
Sponsored by
Biofabri, S.L
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring non-muscle invasive bladder tumors

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Basurto
  • Complejo Hospitalario Puerta Del Mar
  • Complexo Hospitalario Universitario A Coruña
  • Complejo Hospitalario Regional Reina Sofía
  • Hospital Universitario Virgen de Las NievesRecruiting
  • Complejo Hospitalario Médico Quirúrjico de Jaén
  • Hospital de Especialidades de Jerez de La Frontera
  • Hospital Fundacion Jimenez Diaz
  • Hospital Universitario 12 de Octubre
  • Complejo Universitario La Paz
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Complejo Hospitalario Regional de Málaga
  • Hospital Universitario Central de Asturias
  • Clinica Universidad de Navarra
  • Hospital Clínico Universitario de Valladolid

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treated with IMUNO BCG Moreau RJ adjuvant.

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Disease-free survival.
The secondary objective is to assessment the disease-free survival.
Assessment of the quality of life
Assessment will be measure with FACT-BL version4th
Assessment of adverse reactions
Assessment will be measure in number and relation with IMP
Assessment of the dropout rate due to toxicity
Assessment will be measure in number

Full Information

First Posted
June 7, 2019
Last Updated
June 10, 2019
Sponsor
Biofabri, S.L
Collaborators
Fundación para la Investigación en Urología (FIU)
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1. Study Identification

Unique Protocol Identification Number
NCT03982797
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 17, 2019 (Actual)
Primary Completion Date
April 3, 2021 (Anticipated)
Study Completion Date
March 3, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biofabri, S.L
Collaborators
Fundación para la Investigación en Urología (FIU)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
non-muscle invasive bladder tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
306 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treated with IMUNO BCG Moreau RJ adjuvant.
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Instillation of IMUNO BCG Moreau RJ
Intervention Description
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 .
Primary Outcome Measure Information:
Title
progression-free survival
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Disease-free survival.
Description
The secondary objective is to assessment the disease-free survival.
Time Frame
24 months
Title
Assessment of the quality of life
Description
Assessment will be measure with FACT-BL version4th
Time Frame
24 months
Title
Assessment of adverse reactions
Description
Assessment will be measure in number and relation with IMP
Time Frame
24 months
Title
Assessment of the dropout rate due to toxicity
Description
Assessment will be measure in number
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ingrid Murillo, MSc.
Phone
0034986330400
Email
ingrid.murillo@biofabri.es
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Barja, MSc.
Phone
0034986330400
Email
sara.barja@biofabri.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Unda, MD
Organizational Affiliation
Hospital Universitario Basurto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Complejo Hospitalario Puerta Del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Complexo Hospitalario Universitario A Coruña
City
Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Venancio Chantada Abal, MD
Email
vchantada@hotmail.com
First Name & Middle Initial & Last Name & Degree
Venancio Chantada Abal, MD
Facility Name
Complejo Hospitalario Regional Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Virgen de Las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Puche Sanz, MD
Email
nacho.puchesanz@gmail.com
First Name & Middle Initial & Last Name & Degree
Ignacio Puche Sanz, MD
Facility Name
Complejo Hospitalario Médico Quirúrjico de Jaén
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital de Especialidades de Jerez de La Frontera
City
Jerez de la Frontera
ZIP/Postal Code
11408
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Complejo Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joaquín Carballido Rodríguez, MD
Email
carballidojoaquin@gmail.com
First Name & Middle Initial & Last Name & Degree
Joaquín Carballido Rodríguez, MD
Facility Name
Complejo Hospitalario Regional de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Bautista Vidal, MD
Email
yenyebaru@hotmail.com
First Name & Middle Initial & Last Name & Degree
Carlos Bautista Vidal, MD
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesús Maria Fernández Gómez, MD
Email
jmfergomez@gmail.com
First Name & Middle Initial & Last Name & Degree
Jesús Maria Fernández Gómez, MD
Facility Name
Clinica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe Villacampa Aubá, MD
Email
fvauba@unav.es
First Name & Middle Initial & Last Name & Degree
Felipe Villacampa Aubá, MD
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Ramón Cortiñas González, MD
Email
jrcorti@gmail.com
First Name & Middle Initial & Last Name & Degree
Jose Ramón Cortiñas González, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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