CIMAvax-EGF in Bladder cancer

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Effect of combined vaccination of CIMAvax-EGF and intravesical BCG in treatment of non-muscle invasive bladder cancer.

Secondary indentifying numbers:

CIM-PL006

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM); Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Eduardo

Last name:

Ibannez Carrillo

Medical Specialty :

1st Degree Specialist in Oncology

Affiliation:

University Hospital “Celestino Hernandez Robau”

Postal address:

No. 564 between Barcelona y Hospital

City:

Santa Clara

País:

Cuba

Zip Code:

50100

Telephone:

+53-42279401

Email address:

ecarrillo@hchr.vcl.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Pinar del Rio, Hospital “III Congreso”, Yanet Caveda Rizo, MD. 1st Degree Specialist in Urology.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

16/05/2013

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Non-muscle invasive bladder cancer

Health condition(s) code:

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Carcinoma in Situ

Carcinoma

Urinary Bladder Diseases

Urologic Diseases

Intervention(s):

Group I (experimental) CIMAvax-EGF+BCG: Immunization an intramuscular injection of 2.4 mg of CIMAvax-EGF, distributed in four separate anatomic sites (600 μg antigen/site), administered bi-weekly for the first four doses (induction phase), followed by monthly immunizations for the rest of the trial. Also receive intravesical BCG in a formulation of 50 mg/5 mL with 106 bacilli of tuberculosis for each milligram of the product. The treatment with intravesical BCG for both arms comprehended the next schedule: six doses intravesical were administered of BCG formulation diluted in 60 mL of physiological saline (NaCl 7%), spaced by seven days each dose. For the month 3 and 6 of treatment, the BCG administration kept three instillations (one every week), keep going with a semester frequency for the next two years of the study. In this group, concomitance was since the first immunization. Group II (Control) BCG: This group will receive standard care of treatment with intravesical BCG, as described above.

Intervention code:

Epidermal Growth Factor

EGF Family of Proteins

Injections, Intramuscular

Administration, Intravesical

Intervention keyword:

BCG intravesical, CIMAvax EGF vaccine

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Two years recurrence rate (proportion of patients with recurrence/total of patients). Measurement time: 2 years

Key secondary outcomes:

Related with efectivity 1. Recurrence rate per year (proportion of patients with recurrence/total of patients). Measurement time: Follow up every year until 2 years after recruitment. 2. Relapse-free time (time in which a new lesion is not detected since inclusion in the trial, measured in months). Measurement time: Follow up every year until 2 years after recruitment. Related with Safety 3. Adverse Events-AE (Occurrence of any AE (1. yes / 2. no), Description of the AE (Name of the EA), Duration of the AE (Differences between the start and end date of the AE), Intensity of the AE (1. Light, 2. Moderate, 3. Severe, 4. Very severe, 5. Death), Severity (1. Serious / 2. Not serious), Result (1. Recovered, 2. Improved, 3. Persists or Sequelae), Attitude towards treatment (1. No change, 2. Dose modification, 3. Temporary interruption or 4. Definitive interruption), Causal relationship (1. Very Probable / certain / definitive, 2. Probable, 3. Possible, 4. Unlikely, 5. Unrelated, 6. Unknown), Lot of CIMAvax EGF Vaccine (The number of administered vaccine lot)). Measurement Time: Follow up every month until 2 years after recruitment.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1. Patients diagnosed with NMIBC, confirmed by RTU or partial cystectomy. 2. Eligible patients’ are 18 years or older. 3. Non-other cancer previously diagnosed. 4. Capable to sign the informed consent for the investigation. 5. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status index ranging from 0 to 3.

Exclusion criteria:

1. Patients who have previously received treatment with the therapeutic vaccine CIMAvax®EGF and / or Nimotuzumab (Therapeutic monoclonal antibody hR3), or any other product under investigation. 2. Patients whose biopsy sample was not useful to define the degree of tumor infiltration or because the degree of tumor differentiation and infiltration was not reported in the pathology report. 3. Patients of childbearing age who do not use adequate contraceptive methods (intrauterine devices, barrier methods or tubal ligation). 4. Pregnant or lactating patients. 5. Patients with acute allergic states or history of severe allergic reactions. 6. Patients who present psychiatric or neurological diseases with an inability to understand or sign the informed consent. 7. Contraindication for the use of intravesical BCG treatment.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

N/A

Target sample size:

40

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Maurenis

Last Name:

Hernandez Perez

Specialty:

1st Degree Specialist in Oncology

Affiliation:

Center of Molecular Immunology

Postal Address:

216 esq.15, Atabey, Playa, A. Postal 16040, La Habana, Cuba.

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+53-72717933

Email :

maurenis@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Danay

Last Name:

Saavedra Hernandez

Specialty:

1st Degree Specialist in Immunology and Family medicine.

Affiliation:

Center of Molecular Immunology

Postal Address:

216 esq.15, Atabey, Playa, A. Postal 16040

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+53-72717933

Email :

danays@cim.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

University Hospital “Celestino Hernandez Robau”

Hospital "III Congreso"

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

07/01/2013

20/12/2012

Postal address of Ethic Committee :

No. 564 between Barcelona y Hospital, CP. 50100, Santa Clara, Cuba

Calle 2da. Reparto Casanova Alt. Central

Telephone:

+53-42-279401

+53-8262473

Correo electrónico:

direccion@hchr.vcl.sld.cu

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About study completion

Section to complete the data related to the study completion.

Final enrolment number:

40

Study completion date:

15/10/2018

Date of available results:

31/10/2019

Date of first publication:

15/09/2020

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000331

Date of Registration in Primary Registry:

11/08/2020

Record Verification Date:

2020/08/11

Next update date:

2021/08/11

Link to the spanish version:

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Proceso de Registro

CIMAvax-EGF in Bladder cancer

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