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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Nicola Fenwick, BMedSc
+44 121 415 8782
n.fenwick@bham.ac.uk


Study Location:

Bristol Royal Hospital for Children
Bristol


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A Study Evaluating the Safety and Activity of Pegylated Recombinant Human Arginase (BCT-100)

Not Recruiting

Open to: All Genders

Age: 1 Year - 25 Years

Medical Conditions

Cancer
Pediatric Solid Tumor
Pediatric AML
Pediatric ALL


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




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, neuroblastoma, sarcoma and high grade gliomas (brain cancers). Currently the outcomes for these patients are poor and the therapeutic options are limited with a significant toxicity burden. Therefore new treatments which work in different ways to standard chemotherapy are urgently needed. Research has shown that arginine (a nutrient) is important in the survival of cancer cells. BCT-100 is a drug which can deplete arginine levels and starve cancer cells - a completely new approach. BCT-100 has been tested in adults and shown to be active with almost no side-effects. This trial will test whether this dose of BCT-100 is also safe and active in children with relapsed/refractory leukaemia, neuroblastoma, sarcoma and high grade glioma. The trial will also study how BCT-100 is broken down in the body and look for new biological markers of treatment response. Up to 64 children with relapsed cancers will be recruited over 2 years.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2018

Apr 2021

Interventional

Intervention Type : Drug
Intervention Description : PEGylated recombinant human arginase 1

Intervention Arm Group : Group 1 - Leukaemia;Group 2 - Neuroblastoma;Group 3 - Sarcomas;Group 4 - High Grade Glioma

You can take part if:


Inclusion Criteria: - 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 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




You may not be able to take part if:

This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Bristol Royal Hospital for Children
    Bristol
  • Addenbrookes Hospital
    Cambridge
  • Leeds Children's Hospital
    Leeds
  • Royal Marsden Hospital
    Sutton
  • Royal Hospital for Children
    Glasgow
  • Birmingham Children's Hospital
    Birmingham
  • Royal Manchester Children's Hospital
    Manchester


The study is sponsored by University of Birmingham



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for Trial ID: NCT03455140

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