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

October 6, 2009
January 10, 2013
October 2009
October 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00990587 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hematologic Malignancy
  • Acute Lymphocytic Leukemia
  • Chronic Lymphocytic Leukemia
  • Myelodysplasia
  • Acute Myeloid Leukemia
  • Chronic Myelogenous Leukemia
  • Hodgkin's Disease
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.
Experimental: Ciclopirox Olamine
Patients will take Ciclopirox Olamine at escalating doses depending on when they enter into the trial.
Intervention: Drug: Ciclopirox Olamine
Song S, Christova T, Perusini S, Alizadeh S, Bao RY, Miller BW, Hurren R, Jitkova Y, Gronda M, Isaac M, Joseph B, Subramaniam R, Aman A, Chau A, Hogge DE, Weir SJ, Kasper J, Schimmer AD, Al-awar R, Wrana JL, Attisano L. Wnt inhibitor screen reveals iron dependence of β-catenin signaling in cancers. Cancer Res. 2011 Dec 15;71(24):7628-39. doi: 10.1158/0008-5472.CAN-11-2745. Epub 2011 Oct 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
October 2013
October 2013   (final data collection date for primary outcome measure)

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%
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00990587
CPX V001
Yes
University Health Network, Toronto
University Health Network, Toronto
The Leukemia and Lymphoma Society
Principal Investigator: Mark Minden, MD Princess Margaret Hospital, Canada
University Health Network, Toronto
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP