NGcGM3/VSSP in small cell lung cancer

• Register: RPCEC
• Last refreshed on: 1 April 2024
• Main ID: RPCEC00000224
• Date of registration: 07/12/2016
• Prospective Registration: Yes
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: NGcGM3/VSSP in small cell lung cancer
• Scientific title: Active specific immunotherapy with the vaccine preparation NGcGM3 / VSSP in patients with small cell lung cancer
• Date of first enrolment: 01/04/2017
• Target sample size: 40
• Recruitment status: Recruiting
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000224-En
• Study type: Interventional
• Study design: Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment
• Phase: 1-2

Countries of recruitment

Cuba

Contacts

• Name: Elia Neninger Vinageras
• Affiliation: Hermanos Ameijeiras Hospital

• Name: Aliz Mathild Vega Rodriguez
• Affiliation: Center for Molecular Immunology

Key inclusion & exclusion 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: 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.

Age minimum: 18 years
Age maximum: None
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Bronchial Neoplasms

Respiratory Tract Neoplasms

Lung Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Small cell lung cancer

Carcinoma, Bronchogenic

Respiratory Tract Diseases

Thoracic Neoplasms

Intervention(s)

Immunotherapy, Active

Injections, Subcutaneous

NGcGM3/VSSP

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 20 months

Proteolipids

G(M3) Ganglioside

Antineoplastic Agents

Adjuvants, Immunologic

Gangliosides

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Not applicable