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Investigator(s):
Susan Bates, M.D. Principal Investigator Phone: 301-402-5958 sebates@helix.nih.gov
Referral Contact(s):
Christine Bryla, R.N., M.S.N Research Nurse Phone: 301-451-7868 brylacm@mail.nih.gov	Robin Frye, R.N., B.S.N. Research Nurse Phone: 301-402-5958 Fax: 301-496-9781 fryer@mail.nih.gov

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Key Eligibility Criteria:

• Patients with recurrent or advanced cancer (including small-cell lung cancer and other advanced cancers) for whom standard therapy offers no curative potential
• Recovered from prior therapy
• No more than 2 prior cytotoxic regimens
• ECOG performance status 0–2
• Absolute neutrophil count > 1,500/mm³
• Platelets > 100,000/mm³
• Total bilirubin < 1.2 mg/dL (except patients with Gilbert's syndrome)
• AST and ALT ≤ 2.0 x institutional upper limit of normal (ULN)
• Creatinine < 1.5 x ULN OR creatinine clearance > 50 mL/min/1.73 m² for patients with creatinine levels > ULN
• ≥ 18 years of age
• No other histone deacetylase inhibitor for ≥ 2 weeks prior to enrollment
• No history of CNS metastasis unless control has been achieved with either radiation or surgical resection ≥ 3 months prior to enrollment on study
• Patients who have had radiation to the pelvis or other bone marrow-bearing sites will be considered on a case by case basis and may be excluded if the bone marrow reserve is not considered adequate (> 25% of bone marrow)
• No medical condition that would preclude study participation
• HIV negative
• Not pregnant or breast feeding

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Study Outline:

• Belinostat administered by continuous IV infusion (through a vein, over 48 hours) on Days 1–3 of each 21-day cycle
• Cisplatin IV on Day 2, and etoposide IV on Days 2–4
• Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity

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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.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/12/12
Updated: 5/24/12