CIMAvax-EGF vaccine Predictor Phase IV

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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:

Security of CIMAvax-EGF® vaccine for the treatment of patients with NSCLC in advanced stages. Effectiveness exploration according to baseline concentrations of EGF. phase IV

Secondary indentifying numbers:

IICRD-EC-157

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

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:

Trials notification

Regulatory instance:

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

Notification date :

13/10/2015

Reference number:

37.003.15BF4

Principal investigator

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

First name:

Ramon

Midle name:

Alberto

Last name:

Ortiz Carrodeguas

Medical Specialty :

First degree specialist in Oncology

Affiliation:

Celestino Hernandez Robau Hospital

Postal address:

Cuba Street 569, between Hospital and Alejandro Oms, Santa Clara

City:

Villa Clara

País:

Cuba

Zip Code:

50100

Telephone:

+53-042279442

+53-042271202

Email address:

ramonoc@hchr.vcl.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:

Havana, Carlos M. Portuondo Primary Care Unit, Madelaine Serra Urra, MD, Family Doctor

Havana, Elpidio Berovides Primary Care Unit, Barbara de la Caridad Alonso Perez, MD, Family Doctor

Havana, Julio A. Mella Primary care Unit, Dr. Jose Ramon Gomez Perez, MD, Family Doctor

Havana, Lidia y Clodomira Primary care Unit, Miosity Yero Iser, MD, Family Doctor

Havana, Raul Gomez Garcia Primary Care Init, Abel Perez Gonzalez, MD, Family Doctor

Havana, Miguel Enriquez hospital , Juan Carlos Brosales, MD, First Degree Especilist in Oncology

Havana, Luis Galván Primary Care Unit, Zumara Grifi, MD, Family Doctor

Havana, Federico Capdevila Primary Care Unit, Ileana Aransola, MD, First degree specialist in internal Medicine

Havana, Efrain Mayor Primary care Unit, Julio A. Muro, MD, First degree specialist in internal Medicine

Villa Clara, Chiqui Gomez Primary Care unit, Margot Gonzalez Llerena, MD, Family Doctor

Villa Clara, Santa Clara Primary Care unit, Maribel Alonso Ledo, MD, Family Doctor

Villa Clara, XX Aniversario Primary care Unit, Maritza Artiles Morales, MD,Family Doctor

Villa Clara, Jose Ramon Leon Acosta Primary care unit, Lienay Mollineda Leon, MD, Family Doctor

Villa Clara, Marta Abreu Primary care Unit, Menelio Norvel Noriega, MD, Family Doctor

Villa Clara, Roberto Fleites Primary Care unit, Maria Cecilia Garcia Granela, MD, Family Doctor

Research ethics committees:

Celestino Hernandez Robau Hospital, July 28th, 2015

Ethic Comite of Santa Clara Municipality, August 19th, 2015 (Applied for the following primary care units: Chiqui Gomez, Santa Clara, XX Aniversario, Jose Ramon Leon Acosta, Marta Abreu, Roberto Fleites)

Primary care unit "Carlos M. Portuondo", September 17th, 2015

Primary care unit "Elpidio Berovides", October 8th, 2015

Primary care unit "Julio A. Mella", October 22th, 2015

Primary care unit " Lidia y Clodomira", October 19th, 2015

Primary care unit " Raul Gomez Garcia", October 29th, 2015

Miguel Enriquez, September 18th, 2015

Primary care unit "Luis Galvan", October 15th, 2015

Primary care unit "Federico Capdevila", October 8th, 2015

Primary care unit "Efrain Mayor' , September 26th, 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:

14/12/2015

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:

Advanced non small cell lung cancer (NSCLC)

Health condition(s) code:

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Intervention(s):

Experimental group: CIMAvax-EGF therapeutic vaccine. The vaccine will be administrated by intramuscular route, a dose of 2,4 mg. The first four doses (induction stage) will be administered every 14 days and the other doses (maintenance stage) every 28 days until the patient's clinical conditions allow. Prior to the first dose of the vaccine, immunomodulatory dose cyclophosphamide (200 mg / m2, will be administered by intravenous route

Intervention keyword:

CIMAvax-EGF vaccine

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 Event, expected or unexpected, with definite or probable causality relationship with the study product. Measuring time: monthly for two years.

Key secondary outcomes:

Security Related: Adverse Events (AE): Measuring time: inclusion and monthly for two years. Measured as: 1. Occurrence of any AE (yes, no) 2. Description of AE(name of adverse event). 3. Time of onset of AE(difference between start and completion of the EA) 4. Seriousness of AE (1. Serius, 2 No serious) 5. Intensity of AE (1. Light, 2. Moderate 3. Severe, 4. Very severe 5. Death) 6. Causality relationship (1.Very Likely/Safe/final, 2. Likely 3. Possible, 4. Unlikely 5. unrelated 6. Unknown) 7. Attitude followed by the appearance of AE (1. No change 2. Modification of dose 4. 3.Interrupción temporary or definitive interruption) 8. Result of the AE (1. Recovered, 2. Improved , 3. Persists or Consequences.) 9. Batch of vaccine CIMAvax-EGF® (Batch Number of the vaccine) -Hemoglobin (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18 and 24 months -White blood cell count with differential (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Hematocrit (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Platelets (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) (numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Glycemic (Nnumeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Bilirubin (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Alkaline phosphatase (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months Related effectiveness -Time Overall survival (time between inclusion and the date of death of the patient). Measuring time: at baseline, and monthly for two years. -Quality Of life (Questionnaires EORTC QLQ-C30 and EORTC QLQ-CC 13). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -First-line treatment response (Complete response, Partial response, stable desease, Progesion, Not evaluable accoridng to RECIST version 1.1, 2009). Measuring time: at baseline

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 of either sex and greater than or equal to 18 years. 2. Patients who met the diagnostic criteria. 3. Non-eligible patients for chemotherapy or radiotherapy or who have received the treatment oncospecific available and have no other treatment option. 4. Patients who have signed informed consent for research. 5. Patients with clinical criteria status (ECOG) 0 to 3. 6. Patients with a life expectancy greater than or equal to 3 months.

Exclusion criteria:

1. Patients participating in another clinical trial. 2. Patients who have been treated with specific immunotherapy CIMAvax-EGF in the previous 6 months. 3. Patients who present a history of hypersensitivity to compounds similar to the vaccine or other component of the product formulation biological or chemical composition. 4. Patients of childbearing age who are not using an appropriate method of contraception (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). If male (vasectomy, condoms) during treatment 5. Patients who are pregnant, breastfeeding or postpartum. 6. Patients with brain metastases.

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:

4

Target sample size:

Patients to be recruited in two years

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:

Maria

Middle Name:

Acelia

Last Name:

Marrero Miragaya

Specialty:

Fist Degree Specialist in General Surgery

Affiliation:

National Coordinating Center for Clinical Trials

Postal Address:

5ta A,between 60 y 62 Miramar, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+5372164221

Email :

acelia@cencec.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:

Geidy

Last Name:

Lorenzo Monteagudo

Specialty:

BSc. in Farmaceutical Sciences

Affiliation:

Center for Molecular Immunology

Postal Address:

216 Street and 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

16040

Telephone:

+5372717933

Email :

geydi@cim.sld.cu

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:

RPCEC00000205

Date of Registration in Primary Registry:

14/12/2015

Record Verification Date:

2015/12/14

Next update date:

2016/12/14

Link to the spanish version:

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CIMAvax-EGF vaccine Predictor Phase IV

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