A Phase 1 Trial of PXD101 in Combination With 13-cis-Retinoic Acid in Advanced Solid Tumor Malignancies

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed metastatic or
unresectable solid tumor for which standard curative or palliative measures do not
exist or are no longer effective

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)

- Life expectancy of greater than 3 months

- Leukocytes >= 3,000/mcL

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin within normal institutional limits

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 2.5 X institutional upper limit of normal

- Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min
for patients with creatinine levels above institutional normal

- Eligibility of patients receiving any medications or substances known to affect or
with the potential to affect the activity or pharmacokinetics of belinostat will be
determined following review of their case by the Principal Investigator

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation should a woman become pregnant or suspect she
is pregnant while participating in this study, she should inform her treating
physician immediately

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier

- Patients may not be receiving any other investigational agents

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to belinostat or other agents used in study

- Patients should not have taken valproic acid, another histone deacetylase inhibitor,
for at least 2 weeks prior to enrollment

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, or psychiatric illness/social situations that would limit compliance with
study requirements

- A marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a
QTc interval > 500 msec; Long QT Syndrome; the required use of concomitant medication
on belinostat infusion days that may cause Torsade de Pointes

- Significant cardiovascular disease including unstable angina pectoris, uncontrolled
hypertension, congestive heart failure related to primary cardiac disease, a
condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart
disease, or a myocardial infarction within 6 months prior to the trial entry

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with belinostat

- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
therapy are ineligible