NGcGM3/VSSP in Metastatic melanoma

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:

Specific active immunotherapy with the vaccine preparation NGcGM3/VSSP in the treatment of patients with metastatic cutaneous melanoma

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)

Authorization date :

11/06/2012

Reference number:

05-004-12-B

Principal investigator

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

First name:

Marta

Last name:

Osorio Rodriguez

Medical Specialty :

First degree specialist in Oncology

Affiliation:

National Institute of Oncology and Radiobiology (INOR)

Postal address:

29 & F. Vedado, Revolution Square

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78369209

Email address:

mcosorio@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:

Villa Clara, Celestino Hernandez Hospital, Eduardo Ibanez Carrillo MD., I Grade specialist in Oncology

Pinar del Rio, III Congreso Hospital, Lucien Borys Porras MD., I Grade specialist in Oncology

Sancti Spiritus, Camilo Cienfuegos Hospital, Yilian Castro Muncy MD., I Grade specialist in Oncology

Las Tunas, Ernesto Guevara Hospital, Eliecer Santiesteban Gonzalez MD., I Grade specialist in Oncology

Holguin, Vladimir Ilich Lenin Hospital, Yanelis Pereda Mayedo MD., I Grade specialist in Oncology

Santiago de Cuba, Conrado Benitez Hospital, Sandra Gonzalez Fernandez MD., I Grade specialist in Oncology

Research ethics committees:

Celestino Hernandez Hospital, 02/04/2012

III Congreso Hospital, 17/02/ 2016

Camilo Cienfuegos Hospital , 21/01/2016

Ernesto Guevara Hospital , 26/02/2016

Vladimir Ilich Lenin Hospital , 26/02/2016

Conrado Benitez Hospital , 21/01/2016

National Institute of Oncology and Radiobiology, 08/03/2012

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

11/03/2014

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:

Metastatic melanoma

Health condition(s) code:

Melanoma

Nevi and Melanomas

Neuroendocrine Tumors

Neuroectodermal Tumors

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Intervention(s):

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 (control): standard treatment + placebo (subcutaneous), the first 5 doses every 14 days and subsequent doses every 28 days until one year of treatment.

Intervention code:

G(M3) Ganglioside

Adjuvants, Immunologic

Proteolipids

Antineoplastic Agents

Gangliosides

Immunotherapy, Active

Placebos

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):

Overall survival (time from randomization until death from any cause). Measuring time: 24 months.

Key secondary outcomes:

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.

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 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:

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.

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:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

Target sample size:

160

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 of 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:

Marta

Last Name:

Osorio Rodriguez

Specialty:

First degree specialist in Oncology

Affiliation:

National Institute of Oncology and Radiobiology (INOR)

Postal Address:

29 & F. Vedado, Revolution Square

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+5378369209

Email :

mcosorio@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:

RPCEC00000223

Date of Registration in Primary Registry:

07/12/2016

Record Verification Date:

2017/11/30

Next update date:

2018/11/30

Link to the spanish version:

Click here [3]