Metastatic melanoma
Conditions
Interventions
Group 1 (experimental): standard treatment + 900 mg of the NGcGM3/VSSP vaccine (subcutaneous), the first 5 doses every 14 days and subsequent doses every 28 days until one year of treatment.
Group 2
Antineoplastic Agents
Immunotherapy, Active
Placebos
Injections, Subcutaneous
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who received first-line onco-specific therapy according to the treatment guidelines and who completed the different protocols between 4 and 8 weeks prior to inclusion in the trial. 2. Patients older than 18 years 3. Patients with life expectancy of 6 months or more. 4. Patients with functional capacity assessment less than or equal to 2, according to ECOG criteria. 5. Informed Consent signed.
Exclusion criteria
Exclusion criteria: 1.Patients who are pregnant or breastfeeding. 2.Patients with brain metastases. 3.Patients with acute or chronic infectious diseases. 4.Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the vaccine . 5.Patients with autoimmune diseases. 6.Patients with descompensated chronic diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (time from randomization until death from any cause). Measuring time: 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Antitumor response (RECIST (version 1.1) scale). Measuring time: 3, 6, 9, 12, 15, 18, 21, 24 months. Safety Adverse Events-AE (AE description (Name of the AE), AE Intensity (mild, moderate, severe, life-threatening, death) Causality relationship (very probable, probable, possible, unlikely, not related, not evaluable), Gravity (serious, non serious), Previous knowledge (expected, non expected) Result (recovered, improved, sequelae, death), Treatment (none, medication, surgical procedure, transfusion, other). Measuring time: 3, 6, 9, 12, 15, 18, 21, 24 months. Immunogenicity IgM and IgG against NGcGM3 ganglioside (ELISA). Measuring time: At baseline, 85, 169, 337 days. Recognition and lytic capacity of IgM and IgG antibodies induced by vaccination and directed to NGcGM3 on tumor lines expressing ganglioside (flow cytometry). Measuring time: At baseline, 85, 169, 337 days peripheral blood cells: CD3+, CD3+/CD4+, CD3+/CD8+, T reguladoras (CD4+/CD25+/Foxp3+), CD19+ (células B), NK (CD3-/CD16+/CD56+/CD69+), NKT (CD3+/CD56+). Flow cytometry. At baseline, months 3, 6 and 9. Myeloide derived suppressor cells MDSC: (HLADRlow-/LIN-/CD11b+/CD 14+/CD33+).Flow cytometry. At baseline, months 3, 6 and 9. Anti-HLA-A2: HLA-A2 NY-ESO 1, HLA-A2 Tyrisnase, HLA-A2 GP 100, HLA-A2 Mart-1, HLA-A2 MAGE A1, and MAGE A3 response Flow cytometry. At baseline, months 3, 6 and 9. IL-6 y IL-8. ELISA. At baseline, months 3, 6 and 9. | — |
Countries
Cuba
Contacts
Public ContactAliz Vega Rodriguez
Center of Molecular Immunology
Outcome results
None listed