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.