Landscape of early clinical trials for childhood and adolescence cancer in Spain.
OBJECTIVE
Despite numerous advances, survival remains dismal for children and adolescents with poor prognosis cancers or those who relapse or are refractory to first line treatment. There is, therefore, a major unmet need for new drugs. Recent advances in the knowledge of molecular tumor biology open the door to more adapted therapies according to individual alterations. Promising results in the adult anticancer drug development have not yet been translated into clinical practice. We report the activity in early pediatric oncology trials in Spain.


METHODS
All members of the Spanish Society of Pediatric Hematology Oncology (SEHOP) were contacted to obtain information about early trials open in each center.


RESULTS
22 phase I and II trials were open as of May 2015: 15 for solid tumors (68 %) and 7 for hematological malignancies (32 %). Fourteen (64 %) were industry sponsored. Since 2010, four centers have joined the Innovative Therapies For Children With Cancer, an international consortium whose aim is developing novel therapies for pediatric cancers. A substantial number of studies have opened in these 5 years, improving the portfolio of trials for children. Results of recently closed trials show the contribution of Spanish investigators, the introduction of molecularly targeted agents and their benefits.


CONCLUSIONS
Clinical trials are the way to evaluate new drugs, avoiding the use of off-label drugs that carry significant risks. The Spanish pediatric oncology community through the SEHOP is committed to develop and participate in collaborative academic trials, to favor the advancement and optimization of existing therapies in pediatric cancer.
CNIO-HNJ Clinical Research Unit, Servicio de Onco-Hematologia y Transplante, Pediatric Oncology, Hematology and Stem Cell Transplant Department, Hospital Infantil Universitario Niño Jesús, Avenida Menéndez Pelayo, 65, 28009, Madrid, Spain.
F
F
Bautista
Hospital Vall d'Hebron, Barcelona, Spain.
S
S
Gallego
Hospital Universitario y Politécnico La Fe, Valencia, Spain.
A
A
Cañete
Hospital Sant Joan de Déu, Barcelona, Spain.
J
J
Mora
Hospital Vall d'Hebron, Barcelona, Spain.
C
C
Diaz de Heredia
Hospital Sant Joan de Déu, Barcelona, Spain.
O
O
Cruz
Hospital Universitario y Politécnico La Fe, Valencia, Spain.
J M
JM
Fernández
Hospital Sant Joan de Déu, Barcelona, Spain.
S
S
Rives
CNIO-HNJ Clinical Research Unit, Servicio de Onco-Hematologia y Transplante, Pediatric Oncology, Hematology and Stem Cell Transplant Department, Hospital Infantil Universitario Niño Jesús, Avenida Menéndez Pelayo, 65, 28009, Madrid, Spain.
L
L
Madero
Hospital Universitario y Politécnico La Fe, Valencia, Spain.
V
V
Castel
Hospital Gregorio Marañón, Madrid, Spain.
M E
ME
Cela
Hospital Virgen del Rocío, Sevilla, Spain.
G
G
Ramírez
Hospital Vall d'Hebron, Barcelona, Spain.
C
C
Sábado
Hospital Carlos Haya, Málaga, Spain.
T
T
Acha
Hospital Universitario Cruces, Bilbao, Spain.
I
I
Astigarraga
Hospital La Paz, Madrid, Spain.
A
A
Sastre
Hospital Miguel Servet, Zaragoza, Spain.
A
A
Muñoz
Hospital Universitario Son Espases, Palma de Mallorca, Spain.
M
M
Guibelalde
CNIO-HNJ Clinical Research Unit, Servicio de Onco-Hematologia y Transplante, Pediatric Oncology, Hematology and Stem Cell Transplant Department, Hospital Infantil Universitario Niño Jesús, Avenida Menéndez Pelayo, 65, 28009, Madrid, Spain. lmorenom@ext.cnio.es.|Instituto de Investigación La Princesa, Madrid, Spain. lmorenom@ext.cnio.es.
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L
Moreno
D000293:Adolescent; D002648:Child; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008297:Male; D008495:Medical Oncology / Q000379:methods / Q000639:trends*; D009369:Neoplasms / Q000628:therapy*; D010372:Pediatrics / Q000379:methods / Q000639:trends*; D013030:Spain
Drug development; Early phase clinical trials; Pediatric hematology and oncology; Personalized medicine