CIMAVax EGF in Lung Cancer in PHC. Phase IV

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:

Safety assessment of CIMAvax-EGF in patients with lung tumors of advanced non-small cell treated in Primary Health Care

Secondary indentifying numbers:

IICRDEC120

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

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:

Trials notification

Regulatory instance:

Center for State Control of the Quality of Drugs(CECMED)

Notification date :

21/07/2009

Reference number:

24-058-09-B

Principal investigator

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

First name:

Lorena

Midle name:

Margarita

Last name:

Rivas Sanchez

Medical Specialty :

1st Degree Specialist in General Medicine

Affiliation:

Ramon Gonzalez Coro Polyclinic

Postal address:

Calle 100 No.3705 e/. 37 y 39, Marianao

City:

Havana City

Country:

Cuba

Zip Code:

Telephone:

+53-2620678

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:

Artemisa, Policlinic Camilo Cienfuegos, Vicente Castro Martinez, MD, Specialist of Integral General Medicine

Pinar del Rio, Policlinic 5 de Septiembre, Dianelis Martínez Rojas, MD, Specialist of Integral General Medicine

Pinar del Rio, Policlinic Hermanos Cruz, Helen Luaces Rosa, MD, Specialist of Integral General Medicine

Pinar del Rio, Policlinic Raul Sanchez, Martha Elena Gomez Vazquez, MD, Specialist of Integral General Medicine

Havana, Policlinic 13 de Marzo, Ileana Avila Rodríguez, MD, Specialist of Integral General Medicine

Havana, Policlinic 19 de Abril, Amarilis Hernández Cabrera, MD, Especialista en Medicina Interna

Havana, Policlinic Antonio Guiteras Holmes, Aivin Cruz Bolaños, MD, Specialist of Integral General Medicine

Havana, Policlinic Carlos J.Finlay, Lorena M.Rivas, MD, Specialist of Integral General Medicine

Havana, Policlinic Carlos M. Portuondo, Madelaine Serra Urra, Specialist of Integral General Medicine

Havana, Policlinic Elpidio Berovides, Yisell Arias Seruelo, MD, Specialist of Integral General Medicine

Havana, Policlinic Jorge Ruíz Rámirez, Dra.Antoiné Costa Valera, MD, Specialist of Integral General Medicine

Havana, Policlinic Julio A. Mella, Dra.Judith Santana, MD, Specialist of Integral General Medicine

Havana, Policlinic Lidia y Clodomira, Miosotis Yero Iser, MD, Specialist of Integral General Medicine

Havana, Policlinic Managua, Francisco Pijuán Rodríguez, MD, Specialist of Integral General Medicine

Havana, Policlinic Marcio Manduley, Rolando Valdés Cruz, MD, Specialist of Integral General Medicine

Havana, Policlinic Mario Muñoz, Lourdes T. Torres Díaz, MD, Specialist of Integral General Medicine

Havana, Policlinic Rafael Valdés, María Nela Vergel, MD, Specialist of Integral General Medicine

Havana, Policlinic Salvador Allende, Alex Valdes Rama, MD, Specialist of Integral General Medicine

Havana, Policlinic Turcios Lima, Joaquin Hernandez Luis, MD, Specialist of Integral General Medicine

Havana, Policlinic Wilfredo Pérez, Alberto Rodríguez Escalante, MD, Specialist of Integral General Medicine

Matanzas, Policlinic 7 de Diciembre, Eduardo Santiesteban, MD, Specialist of first degree in Oncology

Matanzas, Policlinic Carlos J. Finlay Eduardo Santiesteban, MD, Specialist of first degree in Oncology

Matanzas, Policlinic Carlos Verdugo, Eduardo Santiesteban, MD, Specialist of first degree in Oncology

Matanzas, Policlinic José Luis Dubrot, Eduardo Santiesteban, MD, Specialist of first degree in Oncology

Matanzas, Policlinic Samuel Fernández, Eduardo Santiesteban, MD, Specialist of first degree in Oncology

Cienfuegos, Policlinic Aracelio Rodríguez Castillo, Marelis Aguila Ruiz, MD, Specialist of Integral General Medicine

Cienfuegos, Policlinic Cecilio Ruiz de Zarate, Maria A Basanta Molina, MD, Specialist of Integral General Medicine

Cienfuegos, Policlinic Laboral Area 7, Matilde Rodriguez Stuart, MD, Specialist of Integral General Medicine

Cienfuegos, Policlinic Manuel Piti Fajardo in Palmira, Rigoberto Hermida Acosta, MD, Specialist of Integral General Medicine

Cienfuegos, Policlinic O.C. y la Pedraja, Gloria Isabel Lara Calderin, MD, Specialist of Integral General Medicine

Villa Clara, Policlinic Chiqui Gómez , Irma Garcia Hernandez, MD, Specialist of Integral General Medicine

Villa Clara, Policlinic José Ramón León Acosta, Cintia Maria Rodriguez Santos, MD, Specialist of Integral General Medicine

Villa Clara, Policlinic Martha Abreu, Menelio Norvel Noriega, MD, Specialist of Integral General Medicine

Villa Clara, Policlinic Roberto Fleites, Maria Cecilia Garcia Granela, MD, Specialist of Integral General Medicine

Villa Clara, Policlinic Santa Clara, Maribel Alonso Ledo, MD, Specialist of Integral General Medicine

Villa Clara, Policlinic XX Aniversario, Maritza Artiles Morales, MD, Specialist of Integral General Medicine

Sancti Spiritus, Policlinic Arcelio Suarez Bernal, Kinaisi Rodríguez Rodríguez, MD, Specialist of Integral General Medicine

Sancti Spiritus, Policlinic Faustino Pérez, Juan Carlos Morales Valdés, MD, Specialist of Integral General Medicine

Sancti Spiritus, Policlinic Norte, Marileydi Valdivia Muñoz, MD, Specialist of Integral General Medicine

Ciego de Avila, Policlinic Diego del Rosario, Olegario Ruben Sanchez Real, MD, Specialist of Integral General Medicine

Ciego de Avila, Policlinic Docente Norte de Ciego de Avila, Odelaine Guzman Perez, MD, Specialist of Integral General Medicine

Ciego de Avila, Policlinic Raúl Ortiz, Lesyani Lopez Legra, MD, Specialist of Integral General Medicine

Camaguey, Policlinic Julio Antonio Mella, Miriam Sotomayor, MD, Specialist of Integral General Medicine

Camaguey, Policlinic Previsora, Zunilda Rodriguez, MD, Specialist of Integral General Medicine

Las Tunas, Policlinic Gustavo Aldereguia Lima, Mari Onella Silva Silva, MD, Specialist of Integral General Medicine

Las Tunas, Policlinic Romérico Oro, Natacha Pérez, MD, Specialist of Integral General Medicine

Holguin, Policlinic Alcides Pino Bermudez, Marìa de los Angeles Garcel Rodríguez, MD, Specialist of Integral General Medicine

Holguin, Policlinic José Avila Serrano, Jorge Baudilio Vega Abascal, MD, Specialist of Second degrre in Intern Medicine

Holguin, Policlinic Juan Manuel Páez, Alina Katia Laffita Laborit, MD, Specialist of Integral General Medicine

Holguin, Policlinic Mario Gutierrez Ardalla, Rosa Marìa Hernàndez Salazar, MD, Specialist of Integral General Medicine

Holguin, Policlinic Máximo Gómez Báez, Anabel Pérez Leyva, MD, Specialist of Integral General Medicine

Holguin, Policlinic Pedro Diaz Cuello, Marìa Victoria Escalona Dìaz, MD, Specialist of Integral General Medicine

Granma-Bayamo, Policlinic Jimmy Hirzel, Alexis Antonio Ferrer Hernández, MD, Specialist of Integral General Medicine

Granma-Bayamo, Policlinic René Vallejo Ortíz, Isoris Goy Miranda, MD, Specialist of Integral General Medicine

Granma-Manzanillo, Policlinic Angel Alfonso Ortiz Vazquez, Zenaida Carbonell, MD, Specialist of Integral General Medicine

Santiago de Cuba, Policlinic 28 de Septiembre, Odalys Nieves, MD, Specialist of Integral General Medicine

Santiago de Cuba, Policlinic 30 de Noviembre, Heydi Labastida, MD, Specialist of Integral General Medicine

Santiago de Cuba, Policlinic Camilo Torres, Nora Petra, MD, Specialist of Integral General Medicine

Santiago de Cuba, Policlinic José Martí, Vivian Matos, MD, Specialist of Integral General Medicine

Guantanamo, Policlinic Emilio Daudinot Bueno, Manuel Batista, MD, Specialist of Integral General Medicine

Guantanamo, Policlinic Omar Ranedo Pubillones, Yamila Tabio Ferreiro, MD, Specialist of Integral General Medicine

Research ethics committees:

Pinar del Rio, III Congreso hospital (centralized to the province and Artemisa province), 29/11/2010

Havana, Carlos J Finlay hospital (centralized to the province), 21/05/2009

Matanzas, Faculty of Medicine (centralized to the province), 17/11/2010

Cienfuegos, University of Medical Sciences of Cienfuegos (centralized to the province), 11/02/2011

Villa Clara, Province Ethic Committees (UCM-Villa Clara) (centralized to the province), 03/11/2009

Sancti Spiritus, Camilo Cienfuegos hospital (centralized to the province), 25/06/2010

Ciego de Avila, CEI centralized to the province, 11/02/2011

Camaguey, Maria Curie hospital (centralized to the province), 27/10/2010

Las Tunas, Ernesto Guevara hospital (centralized to the province), 05/01/2011

Holguin, Policlinic José Avila Serrano, 09/09/2010

Holguin, Lenin hospital (included the rest of the policlinics to the province), 22/06/2010

Holguin, Policlinic Pedro Diaz Cuello, 22/04/2011

Granma, Carlos Manuel de Cespedes hospital (centralized to the province and included Manzanillo), 20/05/2009

Santiago de Cuba, Saturnino Lora hospital (centralized to the province), 05/11/2010

Guantanamo, Policlinic Emilio Daudinot Bueno, 18/01/2011

Guantanamo, Policlinic Omar Ranedo Pubillones, 22/01/2011

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

13/07/2009

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 advanced Lung Cancer

Intervention(s):

Study group: CIMAvax -EGF therapeutic vaccine. Doses 2.4 mg by intramuscular route following the scheme: The first four vaccines will be administered every 14 days. The rest of vaccines will be administered monthly using the same dose until they change the clinical condition of the patient at the discretion of the principal investigator or patient toxicity. The vaccine is given in four inoculation sites. In each of the four sites of inoculation (both deltoid both gluteal regions), and the amount of EGF is equivalent to 0.6 mg.

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):

Incidence of severe adverse reactions or deaths. Measuring time: at baseline, monthly during 2 years.

Key secondary outcomes:

Adverse Events (AE). Measuring time: at baseline, monthly during 2 years. Measurable by: -Occurrence of any AE (Yes, No) -Description of the AE (Name of the adverse events) -Duration of the AE (difference between the beginning and the end of the AE) -Intensity of the AE (Mild, Moderate, Severe, Extremely Severe, Death) -Severity (Serious, No serious) -Result (Recovered, Enhanced, Persists or squeals) -Attitude towards treatment (Unchanged, Dose modification, Temporary interruption, Definitive interruption) -Causality relationship (Very Likely, Probable, Possible, Unlikely, not related, Unknown) -Batch of CIMAvaxEGF Vaccine (number of the batch of vaccine) Overall survival time (Time in months from the inclusion date until death or last date you have news). Measuring time: at baseline, monthly during 2 years. Evolution of nutritional status (Body mass index: weight / height ² and percentage (%) weight loss). Measuring time: at baseline, monthly during 2 years. Quality of life (EORTC QLQ-C30 y EORTC QLQ-CC 13). Measuring time: at baseline, monthly during 2 years. Changes staggering pain therapy (Absence of Pain: The patient does not require treatment, First step: Nonsteroidal anti-inflammatory drugs (NSAIDs) (aspirin, diclofenac, dipyrone, ibuprofen, indomethacin, naproxen, Paracetamol, Piroxicam) and / or adjuvants, Second step: is added to NSAIDs and adjuvants, a weak opioid (Amicodex, Dextropropoxyphene, Codeine, Tramadol, Demerol) Third step: strong opioids are introduced into the treatment (Morphine, Methadone, Oxycodone, Fentanyl) Fourth step: Blocking peripheral nerves, intraspinal administration, neurosurgery and / or anesthesia). Measuring time: at baseline, monthly during 2 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. Diagnosis NSCLC IIIb / IV in secondary care 2. Either sex, and age equal or greater than 18 years. 3. Eligible No chemotherapy or radiation therapy or who have received the treatment oncospecific available and have no other therapeutic option. 4. Which have signed informed consent for research. 5. Criteria of clinical status ECOG 0-3.

Exclusion criteria:

1. Patients who have previously received treatment with EGF therapeutic vaccine CIMAvax and / or Nimotuzumab (therapeutic monoclonal antibody hR3). 2. Patients with chronic or acute infectious diseases, inflammatory or unbalanced 3. Patients with decompensated diabetes. 4. Patients of childbearing potential not using adequate contraception accept (intrauterine devices, barrier methods, or tubal ligation, hormonal methods). 5. Pregnant patients or nursing. 6. Patients with acute allergic conditions or history of severe allergic reactions. 7. Patients who can not attend or receive the proposed I have difficulties in accessing the APS treatment center.

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:

Target sample size:

1081

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:

Pedro

Middle Name:

Pablo

Last Name:

Guerra Chaviano

Specialty:

Idustrialist Engineer, Master in Clinical Trials

Affiliation:

National Coordinating Center for Clinical Trials (CENCEC)

Postal Address:

Ave 5ta A e/ 60 y 62,Miramar, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+537-2048742

Email :

pedrop@cencec.sld.cu [1]

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 Perez

Specialty:

First degree Specialist in Oncology

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 and 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+537 271-7933 Ext. 3146

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:

RPCEC00000181

Date of Registration in Primary Registry:

05/08/2014

Record Verification Date:

2014/08/05

Next update date:

2015/08/05

Link to the spanish version:

Click here [3]