NGcGM3/VSSP and nimotuzumab in patients with triple negative breast 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:

Immunotherapy with NGcGM3/VSSP and nimotuzumab in metastatic triple negative breast cancer patients. Phase I/II

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) Cuban 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 the Quality of Drugs(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:

Ana

Last name:

de la Torre Santos

Medical Specialty :

II Grade Specialist in Oncology

Affiliation:

Celestino Hernandez Hospital

Postal address:

Cuba #567 . Barcelona y Hospital. Villa Clara

City:

Santa Clara

País:

Cuba

Zip Code:

50100

Telephone:

+53-042279456

Email address:

paliativ@hchr.vcl.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, Rafaela Mayelin Espin Coto, MD. First Grade in Oncology

Holguin, Vladimir I. Lenin Hospital, Diosdado Cruz del Pino, MD. First Grade in Oncology

Santiago de Cuba, Conrado Benitez Hospital, Dayami Durruty Venero, MD. First Grade Oncology

Sancti Spiritus, Camilo Cienfuegos Hospital, Yania Luisa Jimenez Madrigal, MD. First Grade in Oncology

Matanzas, Jose Ramon Lopez Tabranes Hospital, Edadny Medina Carabeo, MD. First Grade in Oncology

Pinar del Rio, III Congreso Hospital, Yosniel Benitez Falero, MD. First Grade in Oncology

Research ethics committees:

Celestino Hernandez Hospital, April 14th, 2016

Vladimir I. Lenin Hospital, May 27th, 2016

Conrado Benitez Hospital, May 13th, 2016

Camilo Cienfuegos Hospital, May 19th, 2016

Jose Ramon Lopez Tabranes Hospital, May 6th, 2016

III Congreso Hospital, May 20th, 2016

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

14/10/2016

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 triple negative breast cancer

Health condition(s) code:

Triple Negative Breast Neoplasms

Neoplasias de la Mama

Enfermedades de la Mama

Intervention(s):

Group 1 (experimental): Oncospecific treatment + NGcGm3 / VSSP (900μg) subcutaneously as follows: the first 5 immunizations every 14 days, and the following immunizations every 28 days, up to 24 months Group 2 (experimental): Oncospecific treatment + nimotuzumab with the first six weekly doses of 200 mg (intravenous), then one dose (200 mg, intravenous) every 14 days, up to 24 months Group 3 (experimental): Oncospecific treatment + NGcGM3/VSSP + Nimotuzumab . Each product will be used the same dosing schedules, frequencies and routes of administration that provided separately

Intervention code:

Antibodies, Monoclonal, Humanized

G(M3) Ganglioside

Adjuvants, Immunologic

Proteolipids

Antineoplastic Agents

Gangliosides

Injections, Subcutaneous

Administration, Intravenous

Intervention keyword:

NGcGM3/VSSP, Nimotuzumab

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 the date of each patient randomization until the date of death, regardless of the cause of death). Measuring time: 24 months.

Key secondary outcomes:

Response variables: Progression-free survival (Time from the date of randomization of the patient to date of progression of metastatic disease, or death from any cause). Measuring time: 24 months. Antitumor response (RECIST (version 1.1) scale). Measuring time: After completed the third cycle and the sixth cycle of first-line chemotherapy for metastatic disease, and then every 4 months up to 24 months. Quality of life (Questionnaires EORTC QLQ-C30 (cancer), EORTC QLQ-BR23 (breast cancer), and EORTC QLQ-BM22 (patients with bone metastases) . Measuring time: At baseline, and at 6, 9, 15 and 24 months Immune response variables: IgM and IgG against NGcGM3 ganglioside (ELISA). Measuring time: At baseline, Third (85), Sixth (169), Twelfth (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, Third (85), Sixth (169), Twelfth (337) days Safety variables: Adverse Events (AE). Measuring time: Time of evaluation: every 3 months until 24 months Description of the AE (Name of the AE) Intensity of the AE (mild, moderate, severe, life-threatening, death) Relationship causality (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)

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1.Female patients with metastatic triple negative breast cancer. 2.Patients who are candidates for treatment with first-line chemotherapy for metastatic disease. 3.Patients with paraffin-embedded samples for evaluation of the expression of NGcGM3 and EGFR. 4.Patients older than 18 years. 5.Patients who consent to participate in the study by signing the informed consent model. 6.Patients with ECOG scale of Performance Status ≤ 2. 7.Patients with normal functioning of organs and bone marrow defined by laboratory parameters.

Exclusion criteria:

1.Patients who have been treated with NGcGm3 / VSSP or Nimotuzumab within 6 months prior to inclusion. 2.Patients who have been included in another clinical trial within 6 months prior to inclusion. 3.Patients with inflammatory carcinoma of the breast. 4.Patients who are pregnant or breastfeeding. 5.Patients with brain metastases. 6.Patients with acute or chronic infectious diseases. 7.Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the vaccine or mAb. 8.Patients with autoimmune diseases. 9.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:

Open

Control group:

Uncontrolled

Study design:

Parallel

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

Last Name:

Vega Rodríguez

Specialty:

Specialist of first degree in Immunology

Affiliation:

Center of Molecular Immunology

Postal Address:

216 & 15. Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

53772717933, 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:

Ana

Last Name:

de la Torre Santos

Specialty:

Specialist of second degree in Oncology

Affiliation:

Celestino Hernandez Hospital

Postal Address:

Cuba #567 e/ Barcelona y Hospital. Villa Clara

City:

Santa Clara

País:

Cuba

Zip Code:

50100

Telephone:

53042279456

Email :

paliativ@hchr.vcl.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:

RPCEC00000218

Date of Registration in Primary Registry:

12/10/2016

Record Verification Date:

2016/12/22

Next update date:

2017/12/22

Link to the spanish version:

Click here [3]