NL-OMON49172
Completed
Phase 2
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 - PARC
Cancer Research UK Clinical Trials Unit0 sites4 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- onbehandelbare en/of terugkerende vorm van kanker: leukemie, hoogradig glioom, neuroblastoom, sarcoom
- Sponsor
- Cancer Research UK Clinical Trials Unit
- Enrollment
- 4
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria
- •\* Aged 1\- \<25 years old at the time of study registration
- •\* Histologically confirmed disease in one of the following four groups:
- •o Group 1 \- Acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia
- •o Group 2 \- Neuroblastoma
- •o Group 3 \- Sarcoma
- •o 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).
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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