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

Phase 1

Completed

• Conditions: Relapsed/refractory cancers of children and young adults; Cancer

• Registration Number: ISRCTN21727048
• Lead Sponsor: niversity of Birmingham

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38357205/ (added 15/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-27
• Study Completion: 2022-10-16
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 49

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
7. Sexually active patients must agree to use adequate and appropriate contraception while on study drug and for 12 months following treatment discontinuation
8. Written informed consent given by patient and/or parents/legal representative

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified