Neuroblastoma
Conditions
Keywords
localized unresectable neuroblastoma, recurrent neuroblastoma, stage 4S neuroblastoma
Brief summary
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.
Detailed description
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.
Interventions
DRUGisotretinoin
GENETICDNA analysis
GENETICpolymerase chain reaction
OTHERlaboratory biomarker analysis
OTHERpharmacological study
Sponsors
Children's Cancer and Leukaemia Group
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed high-risk neuroblastoma * Concurrent isotretinoin as part of clinical treatment PATIENT CHARACTERISTICS: * Not pregnant * Fertile patients must use effective contraception * Has a single- or double-lumen central venous catheter in place PRIOR CONCURRENT THERAPY: * See Disease Characteristics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of isotretinoin | — |
| Toxicity according to NCI CTCAE v.3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response | — |
Countries
United Kingdom
Outcome results
None listed