A Study Evaluating the Safety and Activity of Pegylated Recombinant Human Arginase (BCT-100)
Status:
Recruiting
Trial end date:
2021-04-01
Target enrollment:
Participant gender:
Summary
PARC is an international phase I/II trial evaluating the safety and activity of pegylated
recombinant human arginase (BCT-100) in children and young people with relapsed/refractory
leukaemia, neuroblastoma, sarcoma and high grade gliomas (brain cancers).
Currently the outcomes for these patients are poor and the therapeutic options are limited
with a significant toxicity burden. Therefore new treatments which work in different ways to
standard chemotherapy are urgently needed. Research has shown that arginine (a nutrient) is
important in the survival of cancer cells. BCT-100 is a drug which can deplete arginine
levels and starve cancer cells - a completely new approach. BCT-100 has been tested in adults
and shown to be active with almost no side-effects. This trial will test whether this dose of
BCT-100 is also safe and active in children with relapsed/refractory leukaemia,
neuroblastoma, sarcoma and high grade glioma. The trial will also study how BCT-100 is broken
down in the body and look for new biological markers of treatment response. Up to 64 children
with relapsed cancers will be recruited over 2 years.