Study to assess the age-dependency in the clearance of doxorubicin in children with leukaemia and solid tumours

Phase 2

Completed

Conditions: Paediatric Oncology, Leukaemia (acute), Leukaemia (chronic), Multiple Sites, Leukaemia (acute myeloid), Leukaemia (acute lymphoblastic), Leukaemia (acute promyelocytic)
Cancer
Other leukaemia of unspecified cell type

Registration Number: ISRCTN57509500

Lead Sponsor: ewcastle upon Tyne Hospitals NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

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

Exclusion Criteria

Prior cardiac problems

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be when the data has been collected & analysed from all the 100 patients at the end of the study.<br><br>1. Pharmacokinetic data to enable assessment of age-dependency of doxorubicin in paediatric patients<br>2. Pharmacokinetic data available on 100 paediatric patients including at least 5 patients <1 year old

Secondary Outcome Measures