Non-muscle invasive bladder cancer
Conditions
Interventions
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
Epidermal Growth Factor
EGF Family of Proteins
Injections, Intramuscular
Administration, Intravesical
BCG intravesical,
CIMAvax EGF vaccine
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two years recurrence rate (proportion of patients with recurrence/total of patients). Measurement time: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Cuba
Contacts
Public ContactMaurenis Hernandez Perez
Center of Molecular Immunology
Outcome results
None listed