13-cis-retinoic acid monitoring study
ISRCTN | ISRCTN37126758 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN37126758 |
EudraCT/CTIS number | 2008-003606-33 |
ClinicalTrials.gov number | NCT00939965 |
Secondary identifying numbers | 7898 |
- Submission date
- 18/06/2010
- Registration date
- 18/06/2010
- Last edited
- 04/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Gareth Veal
Scientific
Scientific
Northern Institute of Cancer Research
Paul O'Gorman Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
Phone | +44 191 208 4332 |
---|---|
g.j.veal@newcastle.ac.uk |
Study information
Study design | Multicentre non-randomised interventional treatment trial |
---|---|
Primary study design | Interventional |
Secondary study design | Non randomised controlled trial |
Study setting(s) | GP practice |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Pilot study to investigate the feasibility of 13-cis-retinoic acid pharmacokinetic monitoring in high-risk neuroblastoma patients |
Study acronym | PK 2008 03 |
Study objectives | This study is designed to implement pharmacokinetically guided 13-cis-retinoic acid (Roaccutane) dose adjustment in high-risk neuroblastoma patients. Pharmacokinetic sampling will be carried out on course 1 of treatment and patients who exhibit low drug plasma levels (less than 2 µM), in conjunction with minimal toxicity, will receive an increased dose of 13-cis-retinoic acid on course 2 of treatment. Additional pharmacokinetic sampling will be carried out to monitor plasma concentrations following administration of this increased dose of 13-cis-retinoic acid, again in conjunction with toxicity monitoring. Individualised dosing in patients will then be maintained in order to prevent potentially sub-therapeutic plasma concentrations of 13-cis-retinoic acid being experienced over the remainder of the 13-cis-retinoic acid treatment period. The aim of the study is to achieve consistent plasma concentrations of 13-cis-retinoic acid in high-risk neuroblastoma patients over the 6 month period of treatment. |
Ethics approval(s) | Trent Research Ethics Committee, 15/01/2009, ref: 08/H0405/55 |
Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Paediatric Oncology; Disease: Miscellaneous |
Intervention | 13-cis-retinoic acid (Isotretinoin) is administered orally to all patients at a dose of 160 mg/m2/day (or 5.33 mg/kg/day for children under 12 kg). A course of treatment lasts for 14 days and patients receive a total of 6 courses, with a 14 day period between each course. Patients who experience peak plasma concentrations of Isotretinoin below 2 µM receive a 25% dose increase on the next course of treatment; patients who experience peak plasma concentrations of Isotretinoin below 1 µM receive a 50% dose increase on the next course of treatment. These dose adjustments are only carried out in patients experiencing minimal or no toxicity. Depending on the results obtained from course 1, an additional 10 and a further 5 blood samples may be taken on course 2 and 3 respectively. Therefore, a maximum of 20 blood samples may be collected from patients over three courses of treatment. Blood samples: Five blood samples will be collected from patients at specific time points over a period of 6 hours following the first dose of 13-cis-retinoic acid administeration on day 14 of course 1 of treatment. In addition, a single blood sample will be taken prior to treatment with 13-cis-retinoic acid for genetic analysis. Follow up length: 36 months Study entry: registration only |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | 13-cis-retinoic acid (Roaccutane) |
Primary outcome measure | To examine the feasibility of implementing dose individualisation with 13-cis-retinoic acid (Roaccutane) monitoring in patients undergoing treatment. All outcome measures will be measured upon completion of the study. |
Secondary outcome measures | 1. To ensure that patients are not exposed to potentially sub-optimal plasma concentrations of 13-cis-retinoic acid during long-term treatment 2. To minimize the large inter-patient variation in plasma concentrations of 13-cis-retinoic observed following standard treatment with 13-cis-retinoic acid 3. To obtain preliminary data to investigate the potential impact of 13-cis-retinoic therapeutic monitoring on efficacy and toxicity All outcome measures will be measured upon completion of the study. |
Overall study start date | 17/07/2009 |
Completion date | 31/03/2015 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Child |
Upper age limit | 18 Years |
Sex | Both |
Target number of participants | Planned sample size: 75; UK sample size: 75 |
Total final enrolment | 103 |
Key inclusion criteria | 1. Age less than 18 years at time of registration, either sex 2. Diagnosis of high-risk neuroblastoma 3. Receiving 13-cis-retinoic acid (Roaccutane) as part of clinical treatment 4. Single or double lumen central venous catheter in place 5. Written informed consent 6. Protocol approval by national and local ethics committee, regulatory authority and Trust R&D Departments 7. A negative pregnancy test for women of childbearing potential, and sexually active patients and partners agreeing to undertake adequate contraceptive measures |
Key exclusion criteria | Failure to comply with any of the inclusion criteria |
Date of first enrolment | 17/07/2009 |
Date of final enrolment | 31/03/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Northern Institute of Cancer Research
Newcastle Upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
Website | http://www.newcastle-hospitals.org.uk/ |
---|---|
https://ror.org/05p40t847 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 15/01/2013 | 22/01/2019 | Yes | No |
Plain English results | 04/04/2022 | No | Yes | ||
HRA research summary | 28/06/2023 | No | No |
Editorial Notes
04/04/2022: Plain English results and total final enrolment added.
22/01/2019: Publication reference added
18/11/2016: No publications found in PubMed, verifying study status with principal investigator.