Phase II pharmacokinetic study to assess the age-dependency in the clearance of doxorubicin in paediatric patients with solid tumours and leukaemia - A European paediatric oncology off-patent medicines consortium protocol. - Doxo V1.1
- Conditions
- Acute lymphoblastic leukaemiaEwing SarcomaNeuroblastomaSoft tissue sarcomaWilms tumours
- Registration Number
- EUCTR2009-011454-17-GB
- Lead Sponsor
- niversitatsklinikum Munster
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
•patients = 17 years of age
•plan to receive at least two cycles of doxorubicin
•must be enrolled in a national or European protocol for treatment of Wilms Tumours, Neuroblastoma, Soft tissue sarcoma, Ewing Sarcoma or Acute lymphoblastic leukaemia and must be treated with doxorubicin according to that protocol
Or
Patients < 3 years enrolled or listed in any national or European study protocol for any paediatric malignancy. Treatment with doxorubicin has to be according to that protocol.
•Patient, parents or legal representative(s) must provide written informed consent to participate in the trial according to national regulations. Patients that are able to understand should provide assent to participate in the trial.
•life expectancy of at least 3 month
•Karnofsky performance status of = 70%
•additional blood withdrawal is acceptable for the patient. The decision is left to the investigator
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•prior cardiac problems
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method