Vorinostat in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphoma and Liver Dysfunction
NCT ID: NCT00499811
Last Updated: 2014-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2007-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (enzyme inhibitor therapy)
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.
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.
vorinostat
Given orally
pharmacological study
Correlative studies
Interventions
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vorinostat
Given orally
pharmacological study
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Suresh Ramalingam
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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City of Hope Medical Center
Duarte, California, United States
University of Southern California
Los Angeles, California, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States
National Institutes of Health
Bethesda, Maryland, United States
Wayne State University-Karmanos Cancer Institute
Detroit, Michigan, United States
Montefiore Medical Center
The Bronx, New York, United States
Case Western Reserve University
Cleveland, Ohio, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
West Virginia University Healthcare
Morgantown, West Virginia, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Countries
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Other Identifiers
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NCI-2009-00272
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-07-C-0228
Identifier Type: -
Identifier Source: secondary_id
CDR0000555102
Identifier Type: -
Identifier Source: secondary_id
PCI-UPCI 07-013
Identifier Type: -
Identifier Source: secondary_id
UPCI 07-013
Identifier Type: OTHER
Identifier Source: secondary_id
8057
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00272
Identifier Type: -
Identifier Source: org_study_id
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