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NCT Number: NCT00990587

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

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.

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Key information

Conditions

Hematologic Malignancy Acute Lymphocytic Leukemia Acute Myeloid Leukemia Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Blast Crisis Bone Marrow Diseases Carcinogenesis Cell Transformation, Neoplastic Chronic Disease Chronic Lymphocytic Leukemia Chronic Myelogenous Leukemia Disease Attributes Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hodgkin Disease Hodgkin's Disease Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Myelodysplasia Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vancouver General Hospital, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18
  • 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.
  • ECOG (Eastern Cooperative Oncology Group) performance status < 2.
  • Biochemical values within the following range:
  • Serum creatinine < 2x upper limit of normal.
  • Total bilirubin < 2x upper limit of normal, AST (asparatate aminotransferase) and ALT (alanine aminotransferase) < 5x upper limit of normal.
  • Ability to maintain adequate oral intake of medication.
  • Ability to understand and sign informed consent.
  • Toxicity from prior chemotherapy has resolved

Exclusion criteria

  • Uncontrolled systemic infection.
  • Uncontrolled intercurrent illness
  • Pregnant or breast feeding
  • Active CNS (central nervous system) disease
  • Neurologic symptoms related to intracurrent illnesses or unexplained causes
  • Psychiatric illness that would limit compliance with study
  • 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
  • Concurrent therapy with topical ciclopirox olamine.
  • Use of other investigational anti-cancer therapy within two weeks of study entry.
  • Use of oral or intravenous metal supplements including iron, copper, zinc and nickel.
  • Resting ejection fraction < 50%

Treatment and study plan

Ciclopirox Olamine

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • The Leukemia and Lymphoma Society

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
First posted
Oct 7, 2009
Registry last updated
Jun 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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