Recurrent Neuroblastoma Clinical Trial
Official title:
Phase I Study of Vorinostat in Combination With 13-Cis-retinoic Acid in Patients With Refractory/Recurrent Neuroblastoma
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. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Isotretinoin may help vorinostat work better by making tumor cells more sensitive to the drug. Giving vorinostat together with isotretinoin may be an effective treatment for neuroblastoma.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of vorinostat pediatric suspension
administered daily 4 times per week orally for two weeks, in combination with twice daily
13-cis-retinoic acid ([cisRA], isotretinoin) orally for 14 days to children with refractory
or recurrent neuroblastoma.
II. To define the toxicities of vorinostat administered in combination with cisRA.
SECONDARY OBJECTIVES:
I. To determine the pharmacokinetics of vorinostat given as a pediatric suspension.
II. To describe the relationship of vorinostat pharmacokinetics to the occurrence of
systemic toxicity.
III. To determine the pharmacokinetics of cisRA given in combination with vorinostat.
IV. To describe histone acetylation levels in peripheral blood mononuclear cells after
different doses of vorinostat.
V. To describe, within the context of a Phase I study, the response rate of vorinostat
combined with cisRA in patients with recurrent/refractory neuroblastoma.
VI. To describe the toxicity and response rate of vorinostat at the determined maximal
tolerated dose combined with cisRA in patients ages 22-30 years of age at study entry with
recurrent/refractory neuroblastoma.
OUTLINE: This is a dose-escalation study of vorinostat.
Patients receive isotretinoin orally (PO) twice daily (BID) on days 1-14, PO suspension* of
vorinostat once daily (QD) on days 1-4 of course 1, and capsules of vorinostat PO QD on days
1-4 and 8-11 of course 2 and subsequent courses. Treatment repeats every 28 days for up to
24 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.
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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