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Investigator(s):
Shivaani Kummar, M.D. Principal Investigator Phone: 301-435-5402 kummars@mail.nih.gov
Referral Contact(s):
Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 jbingham@mail.nih.gov	Sonja Crandon, R.N. Research Nurse Phone: 301-594-4325 Fax: 301-480-7281 crandons@mail.nih.gov

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Primary Eligibility:

• Histologically or cytologically confirmed solid malignancy or lymphoma that is metastatic or unresectable
  • Patients with a liver mass, elevated a-fetoprotein level (≥ 500 ng/mL), and positive serology for hepatitis consistent with a diagnosis of hepatocellular carcinoma will be eligible without the need for pathologic confirmation of the diagnosis
• Standard curative or palliative measures do not exist or are no longer effective
• Patients with abnormal liver function will be eligible
  • No distinction will be made between liver dysfunction due to metastases and liver dysfunction due to other causes
  • Patients with biliary obstruction for which a shunt has been placed are eligible, provided the shunt has been in place for at least 10 days prior to the first dose of vorinostat (SAHA) and liver function has stabilized
    • Two measurements at least 2 days apart that put the patient in the same hepatic dysfunction stratum will be accepted as evidence of stable hepatic function
  • No evidence of biliary sepsis
• Patients with gliomas or brain metastases who require corticosteroids or anticonvulsants must be on a stable dose of corticosteroids and seizure free for 1 month prior to study enrollment
  • Patients with known brain metastases should have had brain irradiation (whole brain or gamma knife) more than 4 weeks before starting protocol treatment
  • Patients with unstable or untreated (non-irradiated) brain metastases should be excluded
• Recovered from prior treatment
• No prior vorinostat
• No enzyme-inducing anticonvulsants
• HIV-positive patients on combination antiretroviral therapy are ineligible
• ≥ 18 years
• ECOG performance status ≤ 2
• ANC > 1,500/mm³
• Platelets ≥ 100,000/mm³
• Creatinine within normal limits OR creatinine clearance ≥ 60 mL/min
• No active hemolysis
• Recovered from all prior therapies
• Not pregnant or nursing; fertile patients must use effective contraception
• Must be able to take oral medications on a continuous basis
• No illness that would preclude study participation

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Treatment Plan:

This is a parallel-group, dose-escalation study. Patients are stratified according to level of hepatic dysfunction (normal vs. mild vs. moderate vs. severe).

Part I:

• Vorinostat (SAHA) will be administered as a single oral dose on Day -6 for all patients
• Blood samples are frequently obtained on Day -6 for pharmacokinetic studies

Part II:

• One week later (Day 1), the first cycle of oral vorinostat will be initiated on a continuous daily oral regimen; each treatment cycle 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
• Once the maximum tolerated dose (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 will be followed for 4 weeks

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 8/28/08
Updated: 10/30/07