Small cell lung cancer
Conditions
Interventions
Experimental group: Standard onco-specific treatment + NGcGm3/VSSP vaccine (subcutaneous), dose of 900µg, the first 5 immunizations every 14 days, and the following immunizations every 28 days, up to
Antineoplastic Agents
Immunotherapy, Active
Injections, Subcutaneous
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients with measurable lesions by application of RECIST version 1.1. 2.Patients older than 18 years. 3.Patients who consent to participate in the study by signing the informed consent model. 4.Patients with ECOG scale of Performance Status = 2. 5.Patients with normal functioning of organs and bone marrow defined by laboratory parameters.
Exclusion criteria
Exclusion criteria: 1.Patients who have been treated with NGcGm3 / VSSP within 6 months prior to recruited. 2.Patients who have been included in another clinical trial within 6 months prior to recruited. 3.Patients who are pregnant or breastfeeding. 4.Patients with brain metastases. 5.Patients with acute or chronic infectious diseases. 6.Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the vaccine. 7.Patients with autoimmune diseases. 8.Patients with descompensated chronic diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious Adverse Events related to the vaccine (Adverse Events “serious” with causality relationship “very probable” or “probable”). Measuring time: Every 3 months until 20 months Overall Survival (Time from the date of each patient randomization until the date of death, regardless of the cause of death). Measuring time: 20 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (time from randomization until objective tumor progression or death). Measuring time: 20 months. Antitumor response (RECIST-version 1.1 scale). Measuring time: every 4 months up to 20 months. Immune response: 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. Safety: Adverse Events-AE (Description of the AE (Name of the AE) Intensity of the AE (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, squeals, death), Treatment (none, medication, surgical procedure, transfusion, other). Measuring time: every 3 months up to 20 months. | — |
Countries
Cuba
Contacts
Public ContactAliz Vega Rodriguez
Center for Molecular Immunology
Outcome results
None listed