| Exclusion Criteria: | 1) Renal insufficiency (serum creatinine levels >/= 2 times the upper limit of normal).
2) Concomitant radiotherapy, chemotherapy, or other investigational agents/therapies.
3) Peripheral neuropathy of Grade 3 or greater assessed by a directed neurologic examination, including light touch, pinprick, proprioception, and deep tendon reflexes of the upper and lower extremities; and questioning for symptoms of paresthesia and numbness (FACT/GOG-Ntx: Appendix D).
4) Patients with evidence of clinically significant mucosal or internal bleeding. (For example, a decrease in hemoglobin of greater than 1.5 gm will be considered clinically significant.)
5) Patients with a platelet count < 50,000 cells/mm^3.
6) Patients with an absolute neutrophil count (ANC) of < 1000 cells/mm^3.
7) ALT/SGPT or AST/SGOT levels >/= 2 times the upper limit of normal (ULN) except in patients with documented hepatic metastases.
8) Total bilirubin > 2 times the ULN.
9) Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study. Such examples include infection requiring hospitalization and psychiatric health which would make compliance understanding difficult.
10) Clinically relevant active infection or serious co-morbid medical conditions such as recent (</6 months) MI, unstable angina, difficult to control CHF, uncontrolled HTN, difficult to control cardiac arrhythmias, COPD or chronic restrictive pulmonary disease, and cirrhosis. Examples of uncontrolled HTN and difficult to control cardiac arrhythmias include situations in which patients still have the problem while on medication or patients who have required > two medication changes in the last 6 months in order to control the problem, or cardiac patients with a NYHA classification of > Class II.
11) If WCBP, pregnant, lactating, or not using adequate contraception.
12) As atiprimod is a potent inhibitor of CYP2D6 (a chemical that is produced naturally by the body that processes and eliminates certain types of chemicals), patients taking drugs that are substrates of CYP2D6 (e.g., beta blockers, antidepressants, and antipsychotics; see Appendix G) will be excluded from the study.
13) Received any form of radiotherapy, chemotherapy, or other investigational agents/therapies within 30 days prior to the first dose of study drug. |