Vorinostat in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphoma and Liver Dysfunction

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Vorinostat

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed solid malignancy or lymphoma that is metastatic or unresectable

• Patients with a liver mass, elevated α-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 who have not received any prior therapy for malignancy are also eligible if they are ineligible for standard therapy due to hepatic dysfunction

• 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

• ECOG performance status ≤ 2 (Karnofsky ≥ 60%)

• Life expectancy > 3 months

• Absolute neutrophil count > 1,500/mm^3

• Platelets ≥ 100,000/mm^3

• Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min

• Not pregnant or nursing

• Fertile patients must use effective contraception

• HIV-positive patients without an AIDS-defining diagnosis who are not receiving agents with the potential for pharmacokinetic interactions with vorinostat may be eligible

• Able to take oral medications on a continuous basis

• No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• No active hemolysis

• More than 3 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered

• Patients who have been treated with agents that persist in the body for longer than 4 to 6 weeks (such as suramin) are ineligible during the elimination period for those agents

• More than 14 days since prior major surgery

• No prior vorinostat

• At least 2 weeks since prior valproic acid or other histone deacetylase inhibitors

• More than 4 weeks since other prior investigational agents

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent therapy with enzyme-inducing anticonvulsants

• No concurrent prophylactic granulocyte growth factors during the first cycle of therapy

• No other concurrent investigational or commercial agents or therapies