Spots Global Cancer Trial Database for Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors
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Trial Identification
Brief Title: Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors
Official Title: A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Non Central Nervous System Tumors That Are Amenable to Direct Injection
Study ID: NCT02756845
Conditions
Interventions
Study Description
Brief Summary: This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec administration in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection
Detailed Description: This is a phase 1, multicenter, open-label study of talimogene laherparepvec in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection in the clinical setting. Approximately 18 - 24 pediatric subjects are expected to be enrolled and treated with at least 1 dose of talimogene laherparepvec into 2 cohorts stratified by age. DLT will be evaluated based on at least 9 DLT-evaluable subjects in cohort A1. The DLT evaluation period is 35 days from the initial administration of talimogene laherparepvec.
Keywords
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
AI Dupont Hospital for Children, Wilmington, Delaware, United States
Nemours du Pont Hospital in Florida, Jacksonville, Florida, United States
Ann and Robert H Lurie Childrens Hospital of Chicago, Chicago, Illinois, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
Childrens Hospital of Michigan, Detroit, Michigan, United States
Columbia University Medical Center, New York, New York, United States
Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio, United States
Nationwide Childrens Hospital, Columbus, Ohio, United States
Childrens Hospital of Philidelphia, Philadelphia, Pennsylvania, United States
Universitair Ziekenhuis Gent, Gent, , Belgium
Centre Hospitalier Universitaire Sainte Justine, Montreal, Quebec, Canada
Institut Hematologie et Oncologie Pediatrique, Lyon cedex 08, , France
Centre Hospitalier Universitaire de Marseille - Hopital de la Timone, Marseille cedex 5, , France
Institut Curie, Paris, , France
IRCCS Ospedale Pediatrico Bambino, Roma, , Italy
Hospital Universitario Virgen del Rocio, Sevilla, Andalucía, Spain
Hospital Universitari Vall d Hebron, Barcelona, Cataluña, Spain
Hospital Sant Joan de Deu, Esplugues de Llobregat, Cataluña, Spain
Hospital Universitari i Politecnic La Fe, Valencia, Comunidad Valenciana, Spain
Hospital Universitario Infantil Niño Jesus, Madrid, , Spain
Universitaets-Kinderspital beider Basel, Basel, , Switzerland
Universitaets-Kinderspital, Zuerich, , Switzerland
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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