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

Phase 1

Completed

• Conditions: Acute Lymphocytic Leukemia; Chronic Lymphocytic Leukemia; Hodgkin's Disease; Myelodysplasia; Acute Myeloid Leukemia; Hematologic Malignancy; Chronic Myelogenous Leukemia
• Interventions: Drug: Ciclopirox Olamine

• Registration Number: NCT00990587
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-10-06
• Study First Posted: 2009-10-07
• Primary Completion: 2013-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-19
• Last Update Posted: 2015-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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%

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ciclopirox Olamine	Ciclopirox Olamine	Patients will take Ciclopirox Olamine at escalating doses depending on when they enter into the trial.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To determine the response rate of ciclopirox olamine.	2 years
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 characterize the pharmacokinetics (PK) of ciclopirox olamine in patients with relapsed or refractory hematologic malignancy.	2 years

Trial Locations

Locations (2)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada