ISRCTN21727048
Completed
Phase 1
A 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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Birmingham
- Enrollment
- 49
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38357205/ (added 15/02/2024)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged 1\- \<25 years old at the time of study registration
- •2\. Histologically confirmed disease in one of the following four groups:
- •2\.1\. Group 1 \- Acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML)
- •2\.2\. Group 2 \- Neuroblastoma
- •2\.3\. Group 3 \- Sarcoma
- •2\.4\. Group 4 \- High grade glioma (as defined by 2016 WHO CNS classification)
- •3\. 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)
- •4\. Measurable bone marrow disease (group 1\) or at least one evaluable radiological site of disease (group 2, 3 and 4\)
- •5\. 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
- •6\. Documented negative pregnancy test for female patients of childbearing potential within 7 days of trial entry
Exclusion Criteria
- •1\. Previous treatment with another therapeutic arginine\-depleting drug (bacterial or human) or arginase inhibitor
- •2\. Presence of any \>\= CTCAE grade 3 clinically significant treatment\-related toxicity from prior therapies
- •3\. Pregnant or lactating female
- •4\. Evidence of uncontrolled infection
Outcomes
Primary Outcomes
Not specified
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