Implementation of immunotherapeutical products in cancer clinical trials in Santiago de Cuba
Keywords:
immunotherapeutical products, CIMAher-Nimotuzumab, CIMAvax-EGF and Vaxira-Racotumomab, clinical trial.Abstract
A retrospective descriptive study on the presentation of clinical trials was carried out during 23 years in Santiago de Cuba, with the objective of describing the implementation of 3 immunotherapeutical products (CIMAher-Nimotuzumab, CIMAvax-EGF and Vaxira-Racotumomab) for the treatment of patients with cancer in hospitals and polyclinics from the province. The final reports of each clinical trial and the available information of the promoter center were reviewed from 1992 to 2015. Twenty protocols of clinical trials were implemented by 500 investigators of 25 specialties distributed in 4 hospitals of the province and 4 primary health care areas, where 2 clinical trials in patients with lung cancer were carried out. It was concluded that the implementation of these immunotherapeutical products contributed to the health registration of them, enriching the therapeutic arsenal for the treatment of patients with cancer in Santiago de Cuba, with a high social impact.
Downloads
References
2. Perdomo Leyva D, Herrero Aguirre H, Landazuri Llago S, Griñan Semanat D, Peacok Aldana S. Experiencia en la ejecución de ensayos clínicos multicéntricos en Santiago de Cuba durante 15 años. MEDISAN. 2010 [citado 12 Nov 2015]; 14(1). Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1029-30192010000100018&lng=es&nrm=iso&tlng=es
3. Aguilera Calvo N, Cristo Domínguez IS del, Muñoz Morejón Y, Palomino Machado L, Macías Abraham A. Evaluación de la seguridad del nimotuzumab en pacientes con cáncer de pulmón de células no pequeñas portadores de metástasis cerebral. Rev Electrónica "Dr. Zoilo E. Marinello Vidaurreta". 2015 [citado 9 Feb 2017];40(9). Disponible en: http://revzoilomarinello.sld.cu/index.php/zmv/article/view/311
4. Ramos TC, Vinageras EN, Ferrer MC, Verdecia BG, Rupalé IL, Pérez LM, et al. Treatment of NSCLC patients with an EGF-based cancer vaccine: report of a phase I trial. Cancer Biol Ther. 2006;5(2): 145-9.
5. Bardor M, Nguyen D, Diaz S, Varki A. Mechanism of uptake and incorporation of an immunogenic non human sialic acid N-glycolyolneuraminic acid into human cells. J Biol Chem. 2005; 280(6): 4228-37.
6. Marañón Cardonne T, Landazuri Llago S, Clapé Laffita O, Vaillant Lora L, Mastrapa Cantillo K. Desarrollo y principales resultados en la ejecución de los ensayos clínicos en el Hospital General Docente "Dr. Juan Bruno Zayas Alfonso". MEDISAN. 2016 [citado 9 Feb 2017]; 20(5). Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1029-30192016000500018
7. Martínez Feria F, Acosta Brooks SC, Cobián Caballero CO. Supervivencia libre de progresión de cáncer pulmonar de células no pequeñas en pacientes vacunados con CIMAvax-EGF. MEDISAN. 2015 [citado 9 Feb 2017]; 19(12). Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1029-30192015001200007
8. Cobián Caballero CO, Acosta Brooks SC, Martínez Feria F, Romero García LI. Supervivencia en pacientes con cáncer pulmonar de células no pequeñas vacunados con CIMAvax-EGF. MEDISAN. 2016 [citado 9 Feb 2017]; 20(3):320-8. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1029-30192016000300007&lng=es&nrm=iso&tlng=es
9. Schuchter LM, Hensley ML, Meropol NJ, Winer EP, American Society of Clinical Oncology Chemotherapy and Radiotherapy Expert Panel. 2002 update of recommendations for the use of chemotherapy and radiotherapy protectants: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol. 2002;20(12):2895-903.
10. Lorenzo Monteagudo G, Bermúdez del Sol A, Torres Gemeil O. Ensayos clínicos con medicamentos para el tratamiento del cáncer en la atención primaria de salud. Rev Cubana Farm. 2016 [citado 9 Feb 2017]; 50(4). Disponible en: http://www.revfarmacia.sld.cu/index.php/far/article/view/57
11. Saborido Martín L, Soriano García JL, Álvarez Guerra S, González Hernández Z, Riquelme Abreu I. Evaluación del efecto antitumoral del nimotuzumab combinado con radioquimioterapia en tumores de esófago. Rev Cubana Farm. 2015 [citado 9 Feb 2017]; 49(2). Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75152015000200007&lng=es&nrm=iso&tlng=es
12. Gorry C. The ABCs of Clinical Trials in Cuba. MEDICC Rev. 2016 [citado 9 Feb 2017]; 18(3): 9-14. Disponible en: https://www.ncbi.nlm.nih.gov/pubmed/27510931
Published
How to Cite
Issue
Section
License
All the articles can be downloaded or read for free. The journal does not charge any amount of money to the authors for the reception, edition or the publication of the articles, making the whole process completely free. Medisan has no embargo period and it is published under the license of Creative Commons, International Non Commercial Recognition 4.0, which authorizes the copy, reproduction and the total or partial distribution of the articles in any format or platform, with the conditions of citing the source of information and not to be used for profitable purposes.