Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03455140
Other study ID # RG_16-040
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date August 28, 2018
Est. completion date July 22, 2022

Study information

Verified date September 2022
Source University of Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date July 22, 2022
Est. primary completion date July 22, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Year to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PEG- BCT-100
PEGylated recombinant human arginase 1

Locations

Country Name City State
Australia Women's & Children's Hospital Adelaide
Australia Queensland Children's Hospital Brisbane
Australia Royal Children's Hospital Melbourne Melbourne
Australia Perth Children's Hospital Perth
Australia Children's Hospital Westmead Sydney
Australia Sydney Children's Hospital Sydney
Netherlands Princes Maxima Centrum Utrecht
United Kingdom Birmingham Children's Hospital Birmingham
United Kingdom Bristol Royal Hospital for Children Bristol
United Kingdom Addenbrookes Hospital Cambridge
United Kingdom Royal Hospital for Children Glasgow
United Kingdom Leeds Children's Hospital Leeds
United Kingdom Royal Manchester Children's Hospital Manchester
United Kingdom Royal Marsden Hospital Sutton

Sponsors (1)

Lead Sponsor Collaborator
University of Birmingham

Countries where clinical trial is conducted

Australia,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase I: to establish the recommended phase II dose (RP2D) of BCT-100 in children and young adults as assessed by dose limiting toxicity (DLT) and complete arginine depletion Safety profile as measured by the occurrence/non-occurrence of DLT within 28 days of treatment with BCT-100.
o Optimal dose as measured by the complete depletion of arginine. This is defined as AAD <8µM arginine in the blood after 3 doses of BCT-100.
28 days
Primary Phase II: to determine the activity of single agent BCT-100 against relapsed/refractory leukaemia, neuroblastoma, sarcoma and high grade glioma in children and young adults as measured by disease response after 8 weeks. Disease response (Complete Response (CR) or Partial Response (PR)) after 8 weeks of treatment with BCT-100 After 8 weeks
Secondary The incidence and severity of Adverse Events (AEs) as Assessed by CTCAE v4 Incidence and severity of Adverse Events (AEs) defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4 28 days after treatment completion
Secondary Disease response - Leukaemia Disease response ( CR / PR) according to Cheson criteria Within 1 year
Secondary Disease response - Sarcoma Disease response ( CR / PR) according to RECIST criteria Within 1 year
Secondary Disease response - High Grade Glioma Disease response ( CR / PR) according to RANO criteria Within 1 year
Secondary Disease response - Neuroblastoma Disease response ( CR / PR) according to INCR criteria Within 1 year
Secondary Progression free survival (PFS) Up to three years after registration
Secondary Overall survival (OS). Up to three years after registration
Secondary Maximum Plasma Concentration [Cmax], of BCT-100 in the paediatric population. Up to 24 weeks
Secondary Time to maximum Plasma Concentration [Tmax], of BCT-100 in the paediatric population. Up to 24 weeks
Secondary Minimum Plasma Concentration [Cmin], of BCT-100 in the paediatric population. Up to 24 weeks
Secondary Area Under the Curve [AUC], of BCT-100 in the paediatric population. Up to 24 weeks
Secondary Duration of adequate arginine depletion in blood. BCT-100 concentration in blood Up to 24 weeks
Secondary Duration of adequate arginine depletion in bone marrow . BCT-100 concentration in bone marrow Up to 24 weeks
Secondary Duration of adequate arginine depletion in cerebrospinal fluid. BCT-100 concentration in cerebrospinal fluid Up to 24 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients