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
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 |
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
Has your child been diagnosed with Non-CNS Tumors? |
Yes |
No |