None listed
Conditions
Brief summary
Currently the doses of medication given to treat cancer are generally determined by a simple body surface area (BSA) calculation based on weight and height. However, physiological differences between individuals may affect the way cancer drugs are processed by the body, potentially leading to variable dose levels in the body, and differences in toxicity and efficacy between individuals. This study is looking at the way the body processes the drug doxorubicin (this is called pharmacokinetics and pharmacodynamics), to see if gender, stage of puberty, or body composition may impact the effectiveness or toxicity of doxorubicin. The study focuses on osteosarcoma, Ewing family of tumours and Hodgkin lymphoma because there is some evidence that there may be a difference between males and females in the response to chemotherapy for these cancers. These cancers mainly affect young people, many of whom are undergoing the physical changes of puberty, which are different for males and females.
Interventions
Experimental drug treatments are not part of this study. Patients will receive chemotherapy that is standard of care at their hospital. Blood samples for pharmacokinetics will be collected immediately prior to cycle 1 doxorubicin administration and at 0.5, 1, 3, & 6 hours after the end of the infusion, then at 24, 48 and 72 hours. Pharmacodynamics will be assessed using body composition assessments before patients commence chemotherapy. Body composition will be assessed by height and weight; bio
Experimental drug treatments are not part of this study. Patients will receive chemotherapy that is standard of care at their hospital. Blood samples for pharmacokinetics will be collected immediately prior to cycle 1 doxorubicin administration and at 0.5, 1, 3, & 6 hours after the end of the infusion, then at 24, 48 and 72 hours. Pharmacodynamics will be assessed using body composition assessments before patients commence chemotherapy. Body composition will be assessed by height and weight; bioelectric impedance analysis; X-ray of the wrist to estimate bone age and dual energy X-ray absorptiometry (DEXA) scan.
Sponsors
Australasian Sarcoma Study Group
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Years to 40 Years
Healthy volunteers
No
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
Outcome results
None listed