Status:
COMPLETED
A Study Evaluating the Safety and Activity of Pegylated Recombinant Human Arginase (BCT-100)
Lead Sponsor:
University of Birmingham
Conditions:
Cancer
Pediatric Solid Tumor
Eligibility:
All Genders
1-25 years
Phase:
PHASE1
PHASE2
Brief 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, neurobla...
Eligibility Criteria
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
Exclusion
- Previous treatment with another therapeutic arginine depleting drug (bacterial or human) or arginase inhibitor
- Presence of any ≥ CTCAE grade 3 clinically significant treatment-related toxicity from prior therapies
- Pregnant or lactating female
- Evidence of uncontrolled infection
Key Trial Info
Start Date :
August 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2022
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03455140
Start Date
August 28 2018
End Date
July 22 2022
Last Update
September 2 2022
Active Locations (14)
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1
Women's & Children's Hospital
Adelaide, Australia
2
Queensland Children's Hospital
Brisbane, Australia
3
Royal Children's Hospital Melbourne
Melbourne, Australia
4
Perth Children's Hospital
Perth, Australia