Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000531136 | Registry Identifier | PDQ (Physician Data Query) | |
| EUDRACT-2005-002996-34 | |||
| EU-20643 | |||
| CCLG-CTA-21275/0218/001-0001 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving dactinomycin may help doctors learn how dactinomycin works in the body and how patients will respond to treatment.
PURPOSE: This laboratory study is evaluating the pharmacokinetics of dactinomycin in young patients with cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients undergo blood collection for pharmacokinetic sampling of dactinomycin at baseline (prior to the initiation of dactinomycin) and periodically during course 1 of chemotherapy. An additional blood sample is obtained before or after treatment for the collection of peripheral blood lymphocytes. DNA from these cells is isolated and investigated for genetic variation in genes relevant to the pharmacology of dactinomycin. Plasma concentrations of dactinomycin are determined by liquid chromatography mass spectrometry analysis.
Patients are followed for 2 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| molecular genetic technique | Genetic | |||
| mass spectrometry | Other | |||
| pharmacological study | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PKs) of dactinomycin | ||
| Degree of interpatient variation of drug PKs | ||
| Influence of characteristics such as age, tumor type, and concurrent therapy on drug PKs | ||
| Correlation of drug PKs with clinical response and toxicity, particularly the incidence of severe liver toxicity or veno-occlusive disease |
Not provided
Not provided
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gareth Veal | University of Newcastle Upon-Tyne | Study Chair |
| Alan Boddy, PhD | University of Newcastle Upon-Tyne |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady's Hospital for Sick Children Crumlin | Recruiting | Dublin | 12 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30167756 | Derived | Kim HY, Veal GJ, Zhou F, Boddy AV. The role of solute carrier (SLC) transporters in actinomycin D pharmacokinetics in paediatric cancer patients. Eur J Clin Pharmacol. 2018 Dec;74(12):1575-1584. doi: 10.1007/s00228-018-2544-z. Epub 2018 Aug 30. |
Not provided
Not provided
Not provided
| Birmingham Children's Hospital | Recruiting | Birmingham | England | B4 6NH | United Kingdom |
|
| Institute of Child Health at University of Bristol | Recruiting | Bristol | England | BS2 8AE | United Kingdom |
|
| Addenbrooke's Hospital | Recruiting | Cambridge | England | CB2 2QQ | United Kingdom |
|
| Leeds Cancer Centre at St. James's University Hospital | Recruiting | Leeds | England | LS9 7TF | United Kingdom |
|
| Leicester Royal Infirmary | Recruiting | Leicester | England | LE1 5WW | United Kingdom |
|
| Royal Liverpool Children's Hospital, Alder Hey | Recruiting | Liverpool | England | L12 2AP | United Kingdom |
|
| Middlesex Hospital | Recruiting | London | England | W1T 3AA | United Kingdom |
|
| Great Ormond Street Hospital for Children | Recruiting | London | England | WC1N 3JH | United Kingdom |
|
| Royal Manchester Children's Hospital | Recruiting | Manchester | England | M27 4HA | United Kingdom |
|
| Sir James Spence Institute of Child Health at Royal Victoria Infirmary | Recruiting | Newcastle upon Tyne | England | NE1 4LP | United Kingdom |
|
| University of Newcastle-Upon-Tyne Northern Institute for Cancer Research | Recruiting | Newcastle upon Tyne | England | NE2 4HH | United Kingdom |
|
| Queen's Medical Centre | Recruiting | Nottingham | England | NG7 2UH | United Kingdom |
|
| Oxford Radcliffe Hospital | Recruiting | Oxford | England | 0X3 9DU | United Kingdom |
|
| Children's Hospital - Sheffield | Recruiting | Sheffield | England | S10 2TH | United Kingdom |
|
| Southampton General Hospital | Recruiting | Southampton | England | SO16 6YD | United Kingdom |
|
| Royal Marsden - Surrey | Recruiting | Sutton | England | SM2 5PT | United Kingdom |
|
| Royal Belfast Hospital for Sick Children | Recruiting | Belfast | Northern Ireland | BT12 6BE | United Kingdom |
|
| Royal Aberdeen Children's Hospital | Recruiting | Aberdeen | Scotland | AB25 2ZG | United Kingdom |
|
| Royal Hospital for Sick Children | Recruiting | Edinburgh | Scotland | EH9 1LF | United Kingdom |
|
| Royal Hospital for Sick Children | Recruiting | Glasgow | Scotland | G3 8SJ | United Kingdom |
|
| Childrens Hospital for Wales | Recruiting | Cardiff | Wales | CF14 4XW | United Kingdom |
|
| ID | Term |
|---|---|
| D005820 | Genetic Testing |
| D013058 | Mass Spectrometry |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D002623 | Chemistry Techniques, Analytical |
Not provided
Not provided