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:
University Health Network, Toronto
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
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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:
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Hodgkin Disease
Leukemia
Myelodysplastic Syndromes
U.S. FDA Resources
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:
- 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%
Contacts and Locations
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:
|
Neoplasms Hodgkin Disease Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelodysplastic Syndromes Preleukemia Hematologic Neoplasms Lymphoma Neoplasms by Histologic Type Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms by Site Ciclopirox Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 13, 2013