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CIMAvax-EGF in Bladder cancer
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)
Primary sponsor:
Center of Molecular Immunology (CIM)
Secondary sponsor:
Not applicable
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
Country:
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
Country:
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
Country:
Cuba
Zip Code:
11600
Telephone:
+53-72717933
Email :
danays@cim.sld.cu
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
Yes
Description of Data Sharing Plan:
We will share all data related with baseline characteristics, clinical outcome and data from the laboratory. This information will be shared after the scientific publication of the results obtained and to have access to it. you need to contact with the person listed on this form in the CONTACT FOR PUBLIC QUERIES.
Additional information to share:
No
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
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, Santa Clara, Cuba. CP. 50100
Calle 2da. Reparto Casanova Alt. Central
Telephone:
+53-42-279401
+53-8262473
Email:
direccion@hchr.vcl.sld.cu
-
About study completion
Section to complete the data related to the study completion.
Final enrolment number:
40
Study completion date:
15/10/2018
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:
2020/10/05
Next update date:
2021/10/05
Link to the spanish version:
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