NGcGM3/VSSP in small cell lung 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:

Active specific immunotherapy with the vaccine preparation NGcGM3 / VSSP in patients with small cell lung cancer

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

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:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Elia

Last name:

Neninger Vinageras

Medical Specialty :

Second degree specialist in Oncology

Affiliation:

Hermanos Ameijeiras Hospital

Postal address:

San Lazaro & Belascoain. Centro Habana

City:

Havana

País:

Cuba

Zip Code:

10200

Telephone:

+53-78381950

Email address:

nenin@infomed.sld.cu [1]

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:

Not applicable

Research ethics committees:

Hermanos Ameijeiras Hospital, 08/11/2016

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

01/04/2017

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:

Small cell lung cancer

Health condition(s) code:

Small Cell Lung Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intervention(s):

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

Intervention code:

G(M3) Ganglioside

Adjuvants, Immunologic

Proteolipids

Antineoplastic Agents

Gangliosides

Immunotherapy, Active

Injections, Subcutaneous

Intervention keyword:

NGcGM3/VSSP

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):

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.

Key secondary outcomes:

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.

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 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.

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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

1-2

Target sample size:

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:

Aliz

Middle Name:

Mathild

Last Name:

Vega Rodriguez

Specialty:

First Degree specialist in Immunology

Affiliation:

Center for Molecular Immunology

Postal Address:

Street 216 & 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+5372717933, ext. 3489

Email :

aliz@cim.sld.cu [2]

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:

Elia

Last Name:

Neninger Vinageras

Specialty:

Second degree specialist in Oncology

Affiliation:

Hermanos Ameijeiras Hospital

Postal Address:

San Lazaro & Belascoain. Centro Habana

City:

Havana

País:

Cuba

Zip Code:

10200

Telephone:

+5378381950

Email :

nenin@infomed.sld.cu [1]

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:

RPCEC00000224

Date of Registration in Primary Registry:

07/12/2016

Record Verification Date:

2016/12/07

Next update date:

2017/12/07

Link to the spanish version:

Click here [3]