Trial record 1 of 1 for:    NCT00990587
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Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00990587
First received: October 6, 2009
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • To evaluate the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of ciclopirox olamine. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To evaluate maximum tolerated dose. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To evaluate recommended phase II dose of ciclopirox olamine. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • To determine the response rate of ciclopirox olamine. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To characterize the pharmacokinetics (PK) of ciclopirox olamine in patients with relapsed or refractory hematologic malignancy. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990587

Locations
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
Investigators
Principal Investigator: Mark Minden, MD Princess Margaret Hospital, Canada
  More Information

No publications provided by University Health Network, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00990587     History of Changes
Other Study ID Numbers: CPX V001
Study First Received: October 6, 2009
Last Updated: January 10, 2013
Health Authority: Canada: Health Canada

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:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia
Hodgkin Disease
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Lymphoma
Precancerous Conditions
Ciclopirox
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014