Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy

Phase 1 Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00990587

Enrollment

Registered

2009-10-07

Start date

2009-10-31

Completion date

Unknown

Last updated

2015-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Hematologic Malignancy, Hodgkin's Disease, Myelodysplasia

Keywords

relapsed and refractory hematologic malignancy, ALL (acute lymphoid leukemia), CLL (chronic lymphoid leukemia), High risk myelodysplasia (MDS) with an IPSS (International Prognostic Scoring System) score >2.5, CML (chronic myelogenous leukemia) blast crisis, Relapsed or refractory acute myeloid leukemia (AML)

Brief summary

This is an open-label, single arm study. Approximately 3-30 patients will be enrolled. Patients will receive Oral ciclopirox olamine (aqueous suspension), initial starting dose of 5 mg/m2/day administered as a single dose daily for 5 days. Three patients will initially be treated at each dose level in sequential cohorts. Dose escalation will continue for each subsequent cohort based on toxicity and plasma drug concentrations observed during the previous cohort. Dose escalation will continue until establishment of the maximum tolerated dose (MTD) has been met. Patients who have demonstrated response to treatment, up to 6 total cycles of treatment may be administered. If additional cycles are warranted, ciclopirox olamine will be given at the same dose and frequency as the patient initially received.

Interventions

DRUGCiclopirox Olamine

Patients will take Ciclopirox Olamine at various doses depending on which dose level they come into the study at. Ciclopirox olamine will be administered orally as an aqueous suspension without food. The starting dose will be 5 mg/m2/day administered as a single dose daily for 5 days (one cycle). Once a MTD has been determined, the new patients that enter into the trial will then take it at that level.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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 olamine 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%

Design outcomes

Primary

Measure	Time frame
To evaluate the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of ciclopirox olamine.	2 years
To evaluate maximum tolerated dose.	2 years
To evaluate recommended phase II dose of ciclopirox olamine.	2 years

Secondary

Measure	Time frame
To determine the pharmacodynamic effects of ciclopirox olamine on survivin expression, and relate to the steady-state plasma concentrations of ciclopirox olamine.	2 years
To determine the response rate of ciclopirox olamine.	2 years
To characterize the pharmacokinetics (PK) of ciclopirox olamine in patients with relapsed or refractory hematologic malignancy.	2 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026