Status:
TERMINATED
Study Evaluating the Tolerance and Biological Activity of Oral Clioquinol in Patients With Relapsed or Refractory Hematological Malignancy
Lead Sponsor:
University Health Network, Toronto
Conditions:
Acute Myeloid Leukemia
Acute Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, single arm phase 1 study to evaluate the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of Clioquinol in patients with relapsed or refractory hema...
Detailed Description
This is an open-label, single arm study. Approximately 4-48 patients will be enrolled. Patients will receive 800mg/day of Clioquinol at the start of the trial and the dose will be increased by 800mg w...
Eligibility Criteria
Inclusion
- Relapsed or refractory acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), high risk myelodysplasia (MDS) with an IPSS score \> 2.5, Non-Hodgkin's lymphoma (NHL), Hodgkin's lymphoma (HD) or multiple myeloma, for which all potentially curative or standard salvage therapy options have been exhausted.
- ECOG performance status \< 2.
- Biochemical values within the following range:
- Serum creatinine \< 2x upper limit of normal.
- Total bilirubin \< 2x upper limit of normal, AST and ALT \< 5x upper limit of normal.
- Normal serum B12 level.
- Ability to maintain adequate oral intake of medication.
- Ability to understand and sign informed consent.
- Toxicity from prior chemotherapy has resolved.
Exclusion
- Uncontrolled systemic infection.
- Uncontrolled intracurrent illness.
- Pregnant or breast feeding.
- CNS 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 Clioquinol.
- Prior therapy with Clioquinol.
- Use of other investigational antileukemic therapy within two weeks of study entry.
- Given the neurological side of Clioquinol in the Japanese population, this population, this trial will exclude patients who have a parent of Oriental or Japanese origin or who self-identify as Oriental or Japanese (Appendix 9.2).
- Active ocular problems including visual migraines and glaucoma.
- Use of oral or intravenous heavy metal supplements including copper, zinc, and nickel.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00963495
Start Date
August 1 2009
End Date
September 1 2013
Last Update
June 22 2015
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9