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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00990587
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : June 22, 2015
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hematologic Malignancy Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Myelodysplasia Acute Myeloid Leukemia Chronic Myelogenous Leukemia Hodgkin's Disease Drug: Ciclopirox Olamine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy
Study Start Date : October 2009
Actual Primary Completion Date : May 2013

Arm Intervention/treatment
Experimental: Ciclopirox Olamine
Patients will take Ciclopirox Olamine at escalating doses depending on when they enter into the trial.
Drug: Ciclopirox 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.

Primary Outcome Measures :
  1. To evaluate the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of ciclopirox olamine. [ Time Frame: 2 years ]
  2. To evaluate maximum tolerated dose. [ Time Frame: 2 years ]
  3. To evaluate recommended phase II dose of ciclopirox olamine. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To determine the pharmacodynamic effects of ciclopirox olamine on survivin expression, and relate to the steady-state plasma concentrations of ciclopirox olamine. [ Time Frame: 2 years ]
  2. To determine the response rate of ciclopirox olamine. [ Time Frame: 2 years ]
  3. To characterize the pharmacokinetics (PK) of ciclopirox olamine in patients with relapsed or refractory hematologic malignancy. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00990587

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Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
The Leukemia and Lymphoma Society
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Principal Investigator: Mark Minden, MD Princess Margaret Hospital, Canada
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Health Network, Toronto Identifier: NCT00990587    
Other Study ID Numbers: CPX V001
First Posted: October 7, 2009    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015
Keywords provided by University Health Network, Toronto:
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)
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Hematologic Neoplasms
Hodgkin Disease
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Neoplasms by Site
Precancerous Conditions
Antifungal Agents
Anti-Infective Agents