Neuroblastoma Clinical Trial
Official title:
Pilot Study to Investigate the Feasibility of 13-cis-retinoic Acid Pharmacokinetic Monitoring in High-risk Neuroblastoma Patients
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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
;
Masking: Open Label, Primary Purpose: Treatment
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