Pharmacokinetics of actinomycin D in children with cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002996-34-GB

Enrollment

Registered

2005-10-18

Start date

2006-04-27

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Any children's cancer where this drug is administered as part of the treatment regimen

Interventions

Trade Name: Actinomycin D Product Name: Actinomycin D Pharmaceutical Form: Powder and solvent for suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Not meeting any of the inclusion criteria

Design outcomes

Primary

Measure	Time frame
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. 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. 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). 4. Obtain data on pharmacogenetic variability and relate this to clinical and pharmacokinetic data. ;Secondary Objective: ;Primary end point(s): Accrual of 50 patients	—

Measure

Time frame

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. 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. 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). 4. Obtain data on pharmacogenetic variability and relate this to clinical and pharmacokinetic data. ;Secondary Objective: ;Primary end point(s): Accrual of 50 patients

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026