PARC: This phase I/II trial evaluates the safety and activity of an anti-cancer drug in children or young people with relapsed or refractory leukaemia, neuroblastoma, sarcoma or high grade gliomaA Phase I/II Study Evaluating the Safety and Activity of Pegylated Recombinant Human Arginase (BCT-100) in Relapsed/Refractory Cancers of Children and Young Adults

Inclusion

• Aged 1- <25 years old at the time of study registration

• Histologically confirmed disease in one of the following four groups:

  • Group 1 - Acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML)
  • Group 2 - Neuroblastoma Group 3 - Sarcoma
  • Group 4 - High grade glioma (as defined by 2016 WHO CNS classification)
• Radiological or laboratory evidence of disease progression (during or after completion of first line treatment) or any subsequent recurrence (biopsy at relapse is not mandated).
• Measurable bone marrow disease (group 1) or at least one evaluable radiological site of disease (group 2, 3 and 4).
• Adequate liver function defined as a total bilirubin ≤1.5x the upper limit of normal for age and ALT ≤ 3x the upper limit of normal for age
• Documented negative pregnancy test for female patients of childbearing potential within 7 days of trial entry
• Sexually active patients must agree to use adequate and appropriate contraception while on study drug and for 12 months following treatment discontinuation
• Written informed consent given by patient and/or parents/legal representative