Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma
|ClinicalTrials.gov Identifier: NCT00939965|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : July 15, 2009
Last Update Posted : August 12, 2013
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors plan better treatment for patients receiving isotretinoin.
PURPOSE: This clinical trial is studying the side effects and best dose of isotretinoin in treating young patients with high-risk neuroblastoma.
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: isotretinoin Genetic: DNA analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis Other: pharmacological study||Not Applicable|
- To investigate the feasibility of implementing individualized dosing of isotretinoin in patients with high-risk neuroblastoma after course 1 of treatment, based on isotretinoin pharmacokinetics and toxicity.
- To minimize the large inter-patient variation in plasma concentrations of isotretinoin.
- To ensure that patients are not exposed to potentially sub-optimal plasma concentrations of isotretinoin during long-term treatment, particularly for patients who are not able to swallow isotretinoin capsules.
- To obtain preliminary data on the potential impact of isotretinoin therapeutic monitoring on clinical response and toxicity in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral isotretinoin twice daily on days 1-14. Courses repeat every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and during courses 1-3 for pharmacokinetic studies and determination of each patient's individual therapeutic-dose level requirement. Genotyping to identify genes that metabolize enzymes is conducted via PCR.
After completion of study therapy, patients are followed up periodically for up to 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Investigate the Feasibility of 13-cis-retinoic Acid Pharmacokinetic Monitoring in High-risk Neuroblastoma Patients|
|Study Start Date :||February 2009|
U.S. FDA Resources
- Pharmacokinetics of isotretinoin
- Toxicity according to NCI CTCAE v.3
- Clinical response
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939965
|Great Ormond Street Hospital for Children||Recruiting|
|London, England, United Kingdom, WC1N 3JH|
|Contact: Penelope Brock, MD, PhD 44-20-7829-7924 Brockp@gosh.nhs.uk|
|University of Newcastle-Upon-Tyne Northern Institute for Cancer Research||Recruiting|
|Newcastle-Upon-Tyne, England, United Kingdom, NE2 4HH|
|Contact: Gareth Veal 44-191-246-4332|
|Royal Marsden - Surrey||Recruiting|
|Sutton, England, United Kingdom, SM2 5PT|
|Contact: Andrew David J. Pearson, MD, FRCP, DCh 44-208-661-3163|
|Principal Investigator:||Gareth Veal||University of Newcastle Upon-Tyne|