A study evaluating the safety and activity of a new drug - pegylated recombinant hyman arginase (BCT-100) in cancers in children and young people that have come back (relapsed) or have not responded to treatment (refractory).

Phase 1

• Conditions: Relpased/refractory paeditaric cancers:LeukaemiasSarcomaNeuroblastomaHigh grade glioma (brain cancers); MedDRA version: 21.0Level: PTClassification code 10000830Term: Acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10039494Term: Sarcoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002762-44-IE
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-25
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

•Aged 2- <25 years old
•Histologically confirmed disease in one of the following four cohorts. Patients with and without metastatic lesions are eligible.
oCohort 1 - Acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML)
oCohort 2 - Neuroblastoma
oCohort 3 - Sarcoma
oCohort 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
•Measurable bone marrow disease (cohort 1) or at least one evaluable radiological site of disease (cohort 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
•Normal ECG
•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

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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
• History of an anaphylactic (i.e. life-threatening) reaction to kanamycin.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified