Pharmacokinetic Study of Doxorubicin in Children With Cancer

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Analyze pharmacokinetics of doxorubicin in children with cancer. Furthermore investigate the predictive role of troponin and natriuretic peptides for anthracycline-induced cardiotoxicity .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Muenster
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• 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.

• 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

Exclusion Criteria:

• prior cardiac problems