NANT 2008-02: Phase I Study of Vorinostat in Combination With 13-Cis-Retinoic Acid in Patients With Refractory/Recurrent Neuroblastoma
What is the purpose of this study?
This phase I trial is studying the side effects and the best dose of vorinostat when given together with isotretinoin to see how well it works in treating patients with high-risk refractory or recurrent neuroblastoma.
- Cancer - Neuroblastoma
What is involved?
This is a multicenter, dose-escalation study of vorinostat. Patients receive oral isotretinoin twice daily on days 1-14, oral suspension* of vorinostat once daily on days 1-4 of course 1, and oral capsules of vorinostat once daily on days 1-4 and 8-11 of course 2 and subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Expansion cohort 1 (≤ 21 years of age): Once the maximum-tolerated dose (MTD) has been determined, patients are treated at that dose level as above. Expansion cohort 2 (22-30 years of age): Patients receive isotretinoin as above and vorinostat at the MTD on days 1-3 and 8-10. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients may undergo peripheral blood mononuclear cells collection for pharmacokinetics and histone acetylation studies. After completion of study therapy, patients are followed up periodically. NOTE: Patients less than 10 years of age are encouraged to continue to use oral suspension beyond course 1.
Who should I contact for more information?
Cincinnati Children’s Hospital Medical Center
Cancer and Blood Diseases Institute
3333 Burnet Ave., Cincinnati, OH 45229-3039
Where can I find additional information?