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 |
| ClinicalTrials.gov (NCT) | NCT01095926 |
| Clinical Trials Information System (CTIS) | 2009-011454-17 |
| Protocol serial number | 8609 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Trust (UK) |
| Funder | Commission of the European Communities (Europe) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised, interventional and observational |
| Secondary study design | Non randomised study |
| Study type | Participant 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Doxorubicin |
| Primary outcome measure(s) |
The primary outcome will be when the data has been collected & analysed from all the 100 patients at the end of the study. |
| Key secondary outcome measure(s) |
The outcome of an interim analysis on the data from the first 30 patients is expected to be reported early 2012 |
| Completion date | 28/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 17 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key exclusion criteria | Prior cardiac problems |
| Date of first enrolment | 16/01/2011 |
| Date of final enrolment | 28/02/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Northern Institute of Cancer Research
Newcastle Upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/03/2016: Publication reference added.
