Trials / Unknown
UnknownNCT00939965
Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma
Pilot Study to Investigate the Feasibility of 13-cis-retinoic Acid Pharmacokinetic Monitoring in High-risk Neuroblastoma Patients
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- Children's Cancer and Leukaemia Group · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | isotretinoin | |
| GENETIC | DNA analysis | |
| GENETIC | polymerase chain reaction | |
| OTHER | laboratory biomarker analysis | |
| OTHER | pharmacological study |
Timeline
- Start date
- 2009-02-01
- First posted
- 2009-07-15
- Last updated
- 2013-08-12
Locations
3 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00939965. Inclusion in this directory is not an endorsement.