Condition category
Cancer
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
18/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Gareth Veal

ORCID ID

Contact details

Northern Institute of Cancer Research
Paul O'Gorman Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
+44 191 208 4332
g.j.veal@newcastle.ac.uk

Additional identifiers

EudraCT number

2008-003606-33

ClinicalTrials.gov number

NCT00939965

Protocol/serial number

7898

Study information

Scientific title

Pilot study to investigate the feasibility of 13-cis-retinoic acid pharmacokinetic monitoring in high-risk neuroblastoma patients

Acronym

PK 2008 03

Study hypothesis

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

Trent Research Ethics Committee, 15/01/2009, ref: 08/H0405/55

Study design

Multicentre non-randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

13-cis-retinoic acid (Roaccutane)

Primary outcome measures

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 trial start date

17/07/2009

Overall trial end date

31/03/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned sample size: 75; UK sample size: 75

Participant exclusion criteria

Failure to comply with any of the inclusion criteria

Recruitment start date

17/07/2009

Recruitment end date

31/03/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northern Institute of Cancer Research
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Government

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/11/2016: No publications found in PubMed, verifying study status with principal investigator.