Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I and Pharmacokinetic Study of Vorinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction
This phase I trial is studying the side effects and best dose of vorinostat in treating patients with metastatic or unresectable solid tumors or lymphoma and liver dysfunction. (closed for accrual as of 04/05/2010) Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Vorinostat may have different effects in patients who have changes in their liver function.
PRIMARY OBJECTIVES:
I. Determine the pharmacokinetic disposition of vorinostat (SAHA) in patients with
metastatic or unresectable solid tumors or lymphoma and varying degrees of hepatic
dysfunction.
II. Establish the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of
vorinostat in groups of patients with varying degrees of hepatic dysfunction (mild,
moderate, or severe).
SECONDARY OBJECTIVES:
I. Document the non-DLTs associated with administration of vorinostat in patients with
hepatic dysfunction.
II. Determine the association of the Child-Pugh classification of hepatic dysfunction with
the observed toxicities, plasma pharmacokinetics, and pharmacodynamics of vorinostat
administration.
III. Document any antitumor activity associated with vorinostat treatment in patients
enrolled on this study.
OUTLINE: This is a parallel-group, dose-escalation study. Patients are stratified according
to level of hepatic dysfunction (normal vs mild vs moderate vs severe). (closed for accrual
as of 04/05/2010)
PART I: Vorinostat (SAHA) will be administered as a single oral dose on day -6 for all
patients. Blood samples are obtained periodically on day -6 for pharmacokinetic studies.
PART II: One week later (day 1), the first course of oral vorinostat will be initiated on a
continuous daily oral regimen. Each treatment course will consist of 21 days of therapy.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Dose escalation will proceed within each hepatic dysfunction group (except in the normal
group). Only dose-limiting toxicities (DLTs) that occur during the first cycle of treatment
will be used to guide dose escalation. The maximum tolerated dose (MTD) is the highest dose
at which no more than one instance of DLT is observed (among 6 patients treated). Once the
MTD has been determined for a given hepatic dysfunction group, a maximum of 12 patients will
be accrued to this dose level.
After completion of study treatment, patients are followed for 4 weeks.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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