Hematologic MalignancyPhase 1NCT00990587
Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy
A Phase 1 study testing Ciclopirox Olamine in people with Hematologic Malignancy and Acute Lymphocytic Leukemia, run by University Health Network, Toronto at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia
- What is being tested?
- Ciclopirox Olamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2009to May 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Ability to maintain adequate oral intake of medication.
- Ability to understand and sign informed consent.
- Toxicity from prior chemotherapy has resolved
Who cannot join
- 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
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- 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%
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: 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.
- Conditions
- Hematologic Malignancy, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Myelodysplasia, Acute Myeloid Leukemia, Chronic Myelogenous Leukemia
- Being tested
- Ciclopirox Olamine
- Keywords
- 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)
- Medical subject headings
- Hematologic Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Anemia, Refractory, with Excess of Blasts, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hodgkin Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciclopirox OlamineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ciclopirox Olamine | Experimental | Patients will take Ciclopirox Olamine at escalating doses depending on when they enter into the trial. Receives: Drug: Ciclopirox Olamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of ciclopirox olamine.
Measured: 2 years
To evaluate maximum tolerated dose.
Measured: 2 years
To evaluate recommended phase II dose of ciclopirox olamine.
Measured: 2 years
Secondary outcomes (3)
To determine the pharmacodynamic effects of ciclopirox olamine on survivin expression, and relate to the steady-state plasma concentrations of ciclopirox olamine.
Measured: 2 years
To determine the response rate of ciclopirox olamine.
Measured: 2 years
To characterize the pharmacokinetics (PK) of ciclopirox olamine in patients with relapsed or refractory hematologic malignancy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Leukemia and Lymphoma Society
- Responsible party
- Sponsor
- Investigators
- Mark Minden, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990587
- Sponsor's protocol ID
- CPX V001
- Status last verified
- Jun 2015
- First submitted
- 6 Oct 2009
- Last updated
- 22 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 beta-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.
PubMed 22009536
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy
- ClinicalTrials.gov ID
- NCT00990587
- Acronym / sponsor ID
- CPX V001
- Conditions
- Hematologic Malignancy, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Myelodysplasia, Acute Myeloid Leukemia, Chronic Myelogenous Leukemia
- Keywords
- 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)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- The Leukemia and Lymphoma Society
- Study start
- Oct 2009
- Primary completion
- May 2013 (actual)
- First posted
- 7 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ciclopirox Olamine | Experimental | Drug: Ciclopirox OlaminePatients will take Ciclopirox Olamine at escalating doses depending on when they enter into the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Ability to maintain adequate oral intake of medication.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciclopirox OlaminePatients 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. | Drug | Ciclopirox Olamine |
Primary outcome
To evaluate the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of ciclopirox olamine.
Time frame: 2 years
To evaluate maximum tolerated dose.
Time frame: 2 years
To evaluate recommended phase II dose of ciclopirox olamine.
Time frame: 2 years
3 secondary outcomes
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
To determine the response rate of ciclopirox olamine.
Time frame: 2 years
To characterize the pharmacokinetics (PK) of ciclopirox olamine in patients with relapsed or refractory hematologic malignancy.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
- Derived from this study: PubMed 22009536Song 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 beta-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Minden, MD principal investigator
Princess Margaret Hospital, Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ciclopirox Olamine in people with Hematologic Malignancy and Acute Lymphocytic Leukemia, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of ciclopirox olamine. (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00990587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2015.