Safety Study of Darinaparsin in Combination With Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) to Treat Lymphoma

Exclusion Criteria

• •Arsenic allergy.
• •New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix 3) within 6 months.
• •Myocardial dysfunction defined as scintigraphically- (MUGA \[multiple gated acquisition scan\], myocardial scintigram) or ultrasound-determined left ventricular ejection fraction (LVEF) \<50%.
• •Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a QTc ≥450 msec; or a ≥Grade 2 atrioventricular (AV) block or left bundle branch block (LBBB); or documented history of prolonged QTc.
• •Pregnant and/or lactating women.
• •Uncontrolled systemic infection (documented with microbiological studies).
• •Metastatic brain or meningeal tumors. -Patients with seizure disorder requiring medication (such as anti- branch block (LBBB); or documented history of prolonged QTc.
• •History of confusion or dementia or neurological condition that could mask a potential adverse response to the Study Drug, which may include transient ischemic attack, Parkinson's disease, thrombotic or hemorrhagic stroke, Alzheimer's, and other neurological disorders.
• •Anticancer chemotherapy or immunotherapy for this indication.
• •Radiotherapy during study or within 3 weeks of Study entry.
• •Major surgery within 4 weeks of start of Study Drug dosing.
• •Investigational drug therapy outside of this trial.
• •History of invasive second primary malignancy diagnosed within the previous 3 years except for Stage I endometrial/cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer.
• •Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of Study results.
• •Any condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the Study.