Pharmacokinetics and Pharmacodynamics of Doxorubicin in Children, Adolescents and young adults with Newly Diagnosed Osteosarcoma, Ewing Family of Tumours and Hodgkin Lymphoma A Multi-Institutional Cross-Discipline Non-Therapeutic Study
Not Applicable
Completed
- Conditions
- OsteosarcomaEwing Family of TumoursHodgkin LymphomaCancer - BoneCancer - Children's - Leukaemia & LymphomaCancer - Other cancer types
- Registration Number
- ACTRN12609000956202
- Lead Sponsor
- Australasian Sarcoma Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 79
Inclusion Criteria
Newly diagnosed with osteosarcoma, Ewing family of tumours or Hodgkin lymphoma;
aged between 1 year and 40 years of age; planned treatment involves a standard doxorubicin-containing regimen; written informed consent from patient and/or patient’s parent or legal guardian
Exclusion Criteria
Impaired hepatic function such as known chronic liver disease, evidence of impaired synthetic function or transaminases raised >5 x normal; significant uncontrolled systemic illness as judged by investigator; females who are pregnant or breast feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of gender on the pharmacokinetics of doxorubicin in Adolescent and Young Adult with newly diagnosed Hodgkin lymphoma, osteosarcoma and Ewing family of tumours by comparing doxorubicin concentration-time curve area under the curve (AUC) against gender.[ Cycle 1 of first infusion doxorubicin treatment]
- Secondary Outcome Measures
Name Time Method