Pharmacokinetics of actinomycin D in children with cancer
Phase 1
- Conditions
- Any children's cancer where this drug is administered as part of the treatment regimen
- Registration Number
- EUCTR2005-002996-34-GB
- Lead Sponsor
- niversity Hospitals of Leicester NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
a) Patients being treated with actinomycin D at a UKCCSG centre
a) Age less than or equal to 21 years.
b) Single/double lumen central venous catheter or portocath in place.
c) Written informed consent.
d) Protocol approval by national and local ethics committee.
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
Exclusion Criteria
Not meeting any of the inclusion criteria
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: 1. Build on pilot data obtained in UKCCSG Study PK 2002 04 to further characterise the pharmacokinetics of actinomycin D in a paediatric patient population.<br> 2. Determine the degree of interpatient variation in the pharmacokinetics of actinomycin D in children and investigate the influence of characteristics such as age, tumour type and concomitant therapy on drug pharmacokinetics.<br> 3. Examine relationships between actinomycin D pharmacokinetics and clinical response and toxicity observed in patients, focusing particularly on the incidence of severe liver toxicity or veno-occlusive disease (VOD).<br> 4. Obtain data on pharmacogenetic variability and relate this to clinical and pharmacokinetic data.<br> ;Secondary Objective: ;Primary end point(s): Accrual of 50 patients
- Secondary Outcome Measures
Name Time Method