Study to assess the age-dependency in the clearance of doxorubicin in children with leukaemia and solid tumours
| ISRCTN | ISRCTN57509500 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57509500 |
| EudraCT/CTIS number | 2009-011454-17 |
| ClinicalTrials.gov number | NCT01095926 |
| Secondary identifying numbers | 8609 |
- Submission date
- 02/09/2011
- Registration date
- 02/09/2011
- Last edited
- 29/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Dr Alison Steel
Scientific
Scientific
Northern Institute of Cancer Research
Paul O'Gorman Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
Study information
| Study design | Non-randomised, interventional and observational |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Phase II pharmacokinetic study to assess the age-dependency in the clearance of doxorubicin in paediatric patients with solid tumours and leukaemia |
| Study hypothesis | Doxorubicin is widely used in the treatment of children's cancer, but little is known about how rapidly the drug is metabolised and removed from the body, particularly in very young children. The study brings together investigators in the UK, in France, Germany and Italy to investigate whether the rate of metabolism and removal is related to age or to the toxicity caused by treatment with doxorubicin. Because children's cancer is relatively rare, in order to recruit sufficient patients it is necessary to run the study in multiple clinical centres across four different countries. This study is funded by the FP7-programme of the European Union, specifically to obtain information on drugs like doxorubicin, where the drug is widely-used, but there are gaps in our knowledge. |
| Ethics approval(s) | Sunderland Research Ethics Committee, 26/04/2010, ref: 10/H090/22 |
| Condition | Paediatric Oncology, Leukaemia (acute), Leukaemia (chronic), Multiple Sites, Leukaemia (acute myeloid), Leukaemia (acute lymphoblastic), Leukaemia (acute promyelocytic) |
| Intervention | 1. Collection of blood sample for genetic analysis 2. Collection of blood samples for drug and toxicity marker analysis |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Doxorubicin |
| Primary outcome measure | The primary outcome will be when the data has been collected & analysed from all the 100 patients at the end of the study. 1. Pharmacokinetic data to enable assessment of age-dependency of doxorubicin in paediatric patients 2. Pharmacokinetic data available on 100 paediatric patients including at least 5 patients <1 year old |
| Secondary outcome measures | The outcome of an interim analysis on the data from the first 30 patients is expected to be reported early 2012 |
| Overall study start date | 16/01/2011 |
| Overall study end date | 28/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100; UK Sample Size: 25 |
| Participant inclusion criteria | 1. Patients less than or equal to 17 years of age 2. Plan to receive at least 2 cycles of doxorubicin 3. Must be enrolled in a national or European protocol for treatment of Wilms 4.Turmours, Neuroblastoma, Soft tissue sarcome, Ewing Sarcoma or Acute lymphoblastic leukaemia and must be treated with doxorubicin according to that protocol or patients under 3 years enrolled or listed in any national or European study protocol for any paediatric malignancy. 5. Patients, parents or legal representative(s) must provide written informed consent to participate in the trial according to national regulations 6. Patients that are able to understand should provide assent to participate in the trial 7. Life expectancy is >3 months 8. Karnofsky performance status of >/=70% 9. Additional blood withdrawal is acceptable to the patient. (the decision is left to the investigator) 10. Either male or female |
| Participant exclusion criteria | Prior cardiac problems |
| Recruitment start date | 16/01/2011 |
| Recruitment end date | 28/02/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Northern Institute of Cancer Research
Newcastle Upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom
| Website | http://www.newcastle-hospitals.org.uk/ |
|---|---|
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Government
Commission of the European Communities (Europe)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2015 | Yes | No |
Editorial Notes
29/03/2016: Publication reference added.
