| Exclusion Criteria: | 1) Patient has >/= Grade 2 peripheral neuropathy on clinical examination within 14 days before enrollment.
2) Renal insufficiency (serum creatinine levels > 2.5 mg/dL).
3) Subjects with evidence of mucosal or internal bleeding and/or platelet refractory (i.e., unable to maintain a platelet count >/= 50,000 cells/mm3).
4) Subjects with an absolute neutrophil count (ANC) < 1000 cells/mm3. Growth factors may not be used to meet ANC eligibility criteria.
5) Subjects with a hemoglobin < 8.0 g/dL.
6) AST (SGOT and ALT (SGPT) >/= 2 x ULN.
7) Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.
8) Clinically relevant active infection requiring intravenous antibiotics.
9) Serious co-morbid medical conditions such as chronic obstructive or chronic restrictive pulmonary disease, and cirrhosis.
10) Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study.
11) Patients with a prior malignancy (within the last 3 years), however patients with adequately treated basel cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer are eligible. Patients with a prior malignancy who have an expected survival from this prior malignancy of greater than 90% at 5 years may also be eligible
12) Female subject is pregnant or breast-feeding.
13) Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
14) Uncontrolled diabetes mellitus (Fasting Blood Sugar > 400 despite medical treatment).
15) Hypersensitivity to acyclovir or similar anti-viral drug.
16) Known history of POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes).
17) Known HIV infection.
18) Known active hepatitis B or C viral infection.
19) Patients taking valproic acid for epilepsy will not be allowed to enroll on this study prior to a 30 day washout period. Patients with epilepsy should take any HDAC inhibitor or HDAC like inhibitor other than calprioic acid. If no other alternative is available, patients taking valprioc acid for epilepsy may enroll after a 30 day washout period. |