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
A study for children and adolescents with advanced non central nervous system (CNS) tumors using study drug Talimogene laherparepvec
Sponsor: Amgen Inc.
Enrolling: Male and Female Patients
IRB Number: AAAQ6917
U.S. Govt. ID: NCT02756845
Contact: Stergios Zacharoulis, MD: 212-305-7212 / sz2764@cumc.columbia.edu
Additional Study Information: The purpose of this study is to find out more about how the study drug called talimogene laherparepvec will be used in children/adolescents/young adults with advanced solid tumors not involving the central nervous system that are available for direct injection. This is a phase 1 study, multicenter, open-label study, that means all subject enrolled in the study will be assigned talimogene laherparepvec. The study drug is a genetically modified virus. The virus' genes were modified in a laboratory to make the virus active in the tumor cell but not in normal cell. Talimogene laherparepvec is given as a direct injection into the tumors with a needle. Male or female subjects aged 2 to 21 years will be enrolled into 2 cohorts stratified by age.
This study is closed
Investigator
Stergios Zacharoulis, MD
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For more information, please contact:
Stergios Zacharoulis, MD
sz2764@cumc.columbia.edu
212-305-7212