Vaxira as adjuvant treatment for non-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:

Open randomized controlled clinical trial in patients with non-small cell lung cancer, stage IB, II and IIIA, treated or not with VAXIRA®, after surgery and adjuvant cisplatin-based chemotherapy

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 Public Ministry of 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:

Juan

Midle name:

Carlos

Last name:

Collado Otero

Medical Specialty :

First degree specialist in Surgery

Affiliation:

National Institute of Oncology and Radiobiology (INOR)

Postal address:

29 Street and F, Vedado, Plaza

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78382590

Email address:

colladootero1996@yahoo.com [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:

National Institute of Oncology and Radiobiology (INOR), July 17th, 2015

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

20/12/2015

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:

Non-Small Cell Lung Cancer (NSCLC)

Health condition(s) code:

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intervention(s):

Study group (Vaccine): VAXIRA®. The patient will receive 1mg/dose by intradermal route. The first five doses every 14 days and every 28 days during two years. After that, the vaccine will be administered every two months if patient's general condition allows. Control group: No treatment, only observation

Intervention code:

Cancer Vaccines

Intervention keyword:

Vaxira adjuvant

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):

Disease-free survival (DFS is defined as the time from randomization until recurrence of tumor or death from any cause). Measuring time: every 3 months during 5 years

Key secondary outcomes:

Overall survival (Time from randomization until death from any cause). Measuring time: 5 years Adverse events (Description of any adverse event using CTCAE version 4). Measuring time: in every administration during 5 years. Quality of Live (Questionnaire developed by INOR: CV-INOR- 26-(V.01)). Measuring time: at baseline and every 3 months during 5 years. Immune response: antibody titers against neu GcGM3 (It will be positive when the inverse of the highest serum dilution giving optical density ≥ 0.25 and twice the value of the pre-immune serum). Measuring time: at baseline and every 3 months during 5 years. Ability to lyse ganglioside expressing cells (It will be positive if percentage of dead cells ≥20 %, after subtracting the pre-immune to hyper-immune percent). Measuring time: at baseline and every 3 months during 5 years.

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-Male and female patients ≥ 18 years with tumors in non-small cell lung and pathologically proven completely resected stage IB, II or IIIA stages. 2-Patients who have signed informed consent for research. 3-Patients where surgical technique for tumor resection patient has been anatomical, involving at least a lobectomy . 4-Patients in the mediastinal lymph node sampling has been carried out by radical mediastinal lymphadenectomy corresponding compartment. 5-Disease-free patients (locoregional metastases or relapse), confirmed by a negative CT study at baseline chest CT scan, upper abdomen and brain CT or MRI. 6-Patients with performance status 0-2 according to ECOG scale. 7-Patients who received adjuvant chemotherapy after surgery, have been completed or not all cycles. 8-Patients who have then received adjuvant chemotherapy, radiotherapy treatment option in accordance with pN. 9-Patients in the time between the end of oncospecific treatment and inclusion in the study does not exceed 2 months. 10-Patients with hepatic, renal and haematological normal functions defined by: -Hemoglobina >= 10 g / L Leukocyte - Total count >= 3.0 x 109 / L Absolute Neutrophil -Count >= 1.5 x 109 / L Platelet -Count >=100 x 109 / L -Bilirubin To the upper limit of normal. -TGP And TGO: up 1.5 times the upper limit of normal value of the institution, or <5 times the upper limit of normal value of the institution, if known the existence of liver metastases. -Fosfatasa Alkaline =< 2.5 times the ULN. -Creatinina: Within normal limits or creatinine clearance> 50 mL / min / 1.73 m2 for patients with creatinine levels above the normal value of the institution.

Exclusion criteria:

1- Stage IIIA patients who received neoadjuvant chemotherapy before surgery. 2- Patients whose primary tumor was removed by segmentectomy or wedge resection. 3- Patients showing any microscopic evidence of residual tumor after surgery (positive BSQ). 4- Patients who have previously received treatment with VAXIRA® vaccine or other immunotherapy. 5- Patients with previous history of cancer, except nonmelanoma skin tumors or carcinoma in situ of the cervix treated properly. 6- Patients with acute infectious diseases, chronic inflammatory or unbalanced. 7- Patients of childbearing age who do not accept use appropriate contraception (intrauterine devices, barrier methods or tubal ligation, hormonal methods). 8- Patients pregnant or breastfeeding. 9- Patients with acute allergic conditions or history of severe allergic reactions. 10- Patients who have received organ grafts. 11- Patients with psychiatric illness or addiction problems that may compromise their ability to give informed consent or to comply with trial procedures.

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:

No intervention

Study design:

Parallel

Phase:

2-3

Target sample size:

120

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:

Maurenis

Last Name:

Hernandez Perez

Specialty:

First degree specialist in Oncology

Affiliation:

Center of Molecular Immunology

Postal Address:

216 & 15 ave , Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+537-2717933 ant 3489

Email :

maurenis@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:

Maurenis

Last Name:

Hernandez Pérez

Specialty:

First degree specialist in Oncology

Affiliation:

Center of Molecular Immunology

Postal Address:

11600

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+537 2717933 ext 3489

Email :

maurenis@cim.sld.cu [2]

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:

RPCEC00000207

Date of Registration in Primary Registry:

15/12/2015

Record Verification Date:

2015/12/15

Next update date:

2016/12/15

Link to the spanish version:

Click here [3]