13-cis-retinoic acid monitoring study

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN37126758

Enrollment

Registered

2010-06-18

Start date

2009-07-17

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

Topic: National Cancer Research Network

Interventions

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

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 exper

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Failure to comply with any of the inclusion criteria

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

England, United Kingdom

Outcome results

None listed

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