Phase 1 Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy
1. Age > 18
2. Relapsed or refractory hematologic malignancies including AML, ALL, CLL, high risk
myelodysplasia (International Prognostic Score >2.5), CML blast crisis, multiple
myeloma, non-Hodgkin's lymphoma, and Hodgkin's lymphoma for which all potentially
curative therapy options have been exhausted.
3. ECOG (Eastern Cooperative Oncology Group) performance status < 2.
4. Biochemical values within the following range:
1. Serum creatinine < 2x upper limit of normal.
2. Total bilirubin < 2x upper limit of normal, AST (asparatate aminotransferase)
and ALT (alanine aminotransferase) < 5x upper limit of normal.
5. Ability to maintain adequate oral intake of medication.
6. Ability to understand and sign informed consent.
7. Toxicity from prior chemotherapy has resolved
1. Uncontrolled systemic infection.
2. Uncontrolled intercurrent illness
3. Pregnant or breast feeding
4. Active CNS (central nervous system) disease
5. Neurologic symptoms related to intracurrent illnesses or unexplained causes
6. Psychiatric illness that would limit compliance with study
7. Receiving other systemic chemotherapy, other than hydroxyurea to control circulating
blast counts, within 10 days of study entry. Hydroxyurea is permitted, however the
dose must be stable and unchanged in the 7 days prior to initiation with ciclopirox
8. Concurrent therapy with topical ciclopirox olamine.
9. Use of other investigational anti-cancer therapy within two weeks of study entry.
10. Use of oral or intravenous metal supplements including iron, copper, zinc and nickel.
11. Resting ejection fraction < 50%