Revisiones para Preventive use of CIMAvax-EGF in patients at high risk of lung cancer. PREVAX | Registro Público Cubano de Ensayos Clínicos

--- 21 Mayo 2021 - 4:50pm por Gladys
+++ 19 Julio 2023 - 3:28pm por Gladys
-/05/21
+/06/15
-/05/21
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Revisión de 19 Julio 2023 - 3:28pm

Preventive use of CIMAvax-EGF in patients at high risk of lung cancer. PREVAX

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.

Acronym of Public Title:

PREVAX

Scientific title:

Preventive use of CIMAvax-EGF in patients at high risk of lung cancer. PREVAX

Acronym of Scientific Title:

PREVAX

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

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

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:

Trials notification

Regulatory instance:

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:

Pedro

Midle name:

Pablo

Last name:

Pino Alfonso

Medical Specialty :

Second Degree Specialist in Pulmonology

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital (HHA)

Postal address:

San Lazaro 701 corner Belascoain. Centro Habana.

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

+53-78761436

Email address:

broncoscopia@hha.sld.cu

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

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

01/06/2021

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:

Lung cancer

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):

CIMAvax®-EGF (Experimental group). CIMAvax®-EGF, 2.4 mg per dose. The first 4 doses will be administered every 14 days and the remaining 4 doses, every 28 days until reaching 8 doses. The duration of the treatment will be 6 months. The product will be administered intramuscularly divided into 4 subdoses, equivalent to 0.6 mg of EGF at each site of inoculation (both deltoid regions and both glutes). Prior to receiving the first dose of the vaccine (72 hours), patients will receive a single dose of cyclophosphamide (CMF) 200 mg / m2 intravenously.

Intervention code:

Immunotherapy, Active

Epidermal Growth Factor

Cyclophosphamide

Injections, Intramuscular

Administration, Intravenous

Intervention keyword:

CIMAvax-EGF

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):

1. EGF concentration (the EGF concentration in the blood of the patients expressed in pg / mL will be determined). Measurement time: At baseline, 14 days (+3) from the end of the induction phase (4th dose of the vaccine) and 14 days (+3) from the evaluation at the end of the study treatment (8th dose of the vaccine) . 2. Anti-EGF antibody titers (measurement of anti-EGF antibody titers will be performed in response to short-term vaccination and will determine if it is ≥ 1: 4000). Measurement time: At baseline, 14 days (+3) after the end of the induction phase (4th dose of the vaccine) and 14 days (+3) after the evaluation at the end of the study treatment (8th dose of the vaccine). 3. Serum IL-6 concentration. (pg / ml). Measurement time: At baseline, weeks 8 and 24. 4. Total bilirubin. (mg / dL). Measurement time: At baseline, weeks 8 and 24. 5. Neutrophil / lymphocyte ratio (neutrophil / lymphocyte ratio). Measurement time: At baseline, weeks 8 and 24. 6. Platelet / lymphocyte ratio (platelet / lymphocyte ratio). Measurement time: At baseline, weeks 8 and 24. 7. Absolute count and frequency of CD4 + T cells (total and%). Measurement time: At baseline, weeks 8 and 24. 7. 8. Absolute count and frequency of CD8 + T cells (total and%). Measurement time: At baseline, weeks 8 and 24. 8. 9. CD4 / CD8 Index (CD4 / CD8 Ratio). Measurement time At baseline, weeks 8 and 24.

Key secondary outcomes:

1. (Occurrence of an AE (Yes, No), Type of AE (according to the CTC version 5.0 nomenclature), Duration of the AE (Differences between the start and end dates of the AE), Intensity of the AE (Light, Moderate, Severe, Severe threatening or incapacitating, Severe causing death, according to CTC version 5.0), Causation of AE (Definitive, Very likely, Probable, Possible, Unrelated, Unknown), Severity of AE (Yes, No. In case of seriousness, it will be classified according to the categories of: causes the death of the patient, threatens life, requires hospitalization or prolongs an existing hospitalization, produces a disability, significant or persistent disability, produces a birth defect or a congenital anomaly), Attitude versus the treatment under study (No changes, Dose modification, Temporary interruption of treatment, Definitive interruption of treatment, according to the attitude decided by the clinical investigator), AE Result (Recovered, Improved, Persists, Sec uelas)). Measurement time: Weeks 0, 2, 4, 6, 8, 10, 14, 18, 22, 24 and 30. 2. Clinical response (For patients included in Cohort A, it will be evaluated through the respiratory function test and the COPD status will be collected at the end of treatment according to the GOLD criteria. For patients included in Cohort B, it will be evaluated through imaging and will collect the control of the disease in local relapse or relapse at a distance). Measurement time: At baseline, and at week 24 from the beginning of CIMAvax-EGF treatment.

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:

79 years

Inclusion criteria:

1. Patients who meet the diagnostic criteria according to the cohort to which they belong. 2. Patients aged ≥ 18 years for lung cancer survivors and between 50 and 79 years for patients at high risk of lung cancer. 3. Patients who do not have imaging evidence of lung cancer, evaluated by CT according to RECIST criteria. 4. Patients of childbearing potential who consent to the use of adequate contraceptive methods (eg, hormonal or barrier methods of contraception, abstinence) before being included in the study. If a woman becomes pregnant or suspects that she is pregnant while she or her partner is participating in this study, she should inform her doctor immediately. 5. Patients who give their informed consent for participation in writing. In addition to the above criteria, patients must meet the following criteria specific to the cohort in which they will be included: Patients at high risk of lung cancer (Cohort A). 1. Document the presence of any of these risk factors • Moderate or severe COPD. • Family history of lung cancer. • Low body mass index. • Recent pneumonia. 2. Have quit smoking in the last 10 years or be a current smoker. 3. Have a history of smoking at least 50 packs / year. 4. Have a pulmonary function test in the last 3 months before inclusion. Early Stage Lung Cancer Survivors (Cohort B). 1. Completion of adjuvant therapy for lung cancer after surgery 3 months prior to enrollment, with no evidence of early disease progression. 2. NSCLC confirmed stage IB to IIIA at initial diagnosis (TNM 8th edition).

Exclusion criteria:

1. Patients clinically unfit to undergo the bronchoscopy procedure. 2. Patients with uncontrolled intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. 3. Stage IIIA non-surgical patients. 4. Patients with mild or very severe COPD. 5. Patients with psychiatric illness and / or social situations that would limit compliance with the study requirements. 6. Pregnant or lactating patients. 7. Patients with other malignancy in the previous 5 years, except skin cancer (non-melanoma). 8. Patients who have received another investigational product within 30 days prior to inclusion. 9. Patients who have received treatment for their disease with immunotherapy. 10. Patients with known immunosuppressive disease (eg, HIV, AIDS, or other immunosuppressive disease). The test is not mandatory. 11. Patients with known hypersensitivity to the components of the vaccine under study or any analogue. 12. Patients requiring steroid treatment equivalent to doses greater than 20 mg of prednisone per day. 13. Patients reluctant or unable to follow the requirements of the protocol

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:

Prevention

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

1

Target sample size:

60

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:

Orestes

Middle Name:

Santos

Last Name:

Morales

Specialty:

Second Degree Specialist in Pharmacology

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Street 216, corner 15, Reparto Atabey. Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+53-72143144

Email :

orestesm@cim.sld.cu

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:

Pedro

Middle Name:

Pablo

Last Name:

Pino Alfonso

Specialty:

Second Degree Specialist in Pulmonology

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital (HHA)

Postal Address:

San Lazaro 701 corner Belascoain. Centro Habana.

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

+53-78761436

Email :

broncoscopia@hha.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Hermanos Ameijeiras Clinical Surgical Hospital (HHA)

Status of evaluation:

In review

Status of evaluation date of Ethic Committee:

07/04/2021

Postal address of Ethic Committee :

San Lazaro 701 corner Belascoain, Centro Habana, Havana, ZC 10300, Cuba

Telephone:

+53-78761000

Correo electrónico:

direccion@hha.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

31/01/2023

Date of available results:

29/09/2023

Date of first publication:

29/12/2023

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:

RPCEC00000370

Date of Registration in Primary Registry:

21/05/2021

Record Verification Date:

2021/06/15

Next update date:

2022/06/15

Link to the spanish version:

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Preventive use of CIMAvax-EGF in patients at high risk of lung cancer. PREVAX

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