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Phase 1 Study Evaluating the Tolerance and Biological Activity of Oral Clioquinol in Patients With Relapsed or Refractory Hematological Malignancy

Phase 1
18 Years
Open (Enrolling)
Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Myelodysplasia, Lymphoma, Non-Hodgkin, Hodgkin's Lymphoma, Multiple Myeloma

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Trial Information

Phase 1 Study Evaluating the Tolerance and Biological Activity of Oral Clioquinol in Patients With Relapsed or Refractory Hematological Malignancy

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 with each subsequent level until the MTD is determined. Patients will
then increase their frequency of the drug. Response to Clioquinol will be determined on day
21 for the 8 and 15 day dosing schedule and on day 28 for the 22 day dosing schedule ( 1
cycle). Patients who have demonstrated a response to the drug will be eligible to receive
up to 5 additional cycles at the same dose and frequency every 21 days.

Inclusion Criteria:

1. 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.

2. ECOG performance status < 2.

3. 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 serum B12 level.

4. Ability to maintain adequate oral intake of medication.

5. Ability to understand and sign informed consent.

6. Toxicity from prior chemotherapy has resolved.

Exclusion Criteria:

1. Uncontrolled systemic infection.

2. Uncontrolled intracurrent illness.

3. Pregnant or breast feeding.

4. CNS 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 Clioquinol.

8. Prior therapy with Clioquinol.

9. Use of other investigational antileukemic therapy within two weeks of study entry.

10. 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).

11. Active ocular problems including visual migraines and glaucoma.

12. Use of oral or intravenous heavy metal supplements including copper, zinc, and

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the dose-limiting toxicity (DLT), maximum tolerated dose, and recommended phase II dose. To partially characterize the pharmacokinetics of Clioquinol in plasma following single and multiple oral dosing.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Mark Minden, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada


Canada: Health Canada

Study ID:




Start Date:

August 2009

Completion Date:

August 2011

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Lymphocytic Leukemia
  • Chronic Lymphocytic Leukemia
  • Myelodysplasia
  • Lymphoma, Non-Hodgkin
  • Hodgkin's Lymphoma
  • Multiple Myeloma
  • clioquinol
  • relapsed and refractory hematologic malignancy
  • ALL
  • HD
  • CLL
  • High risk myelodysplasia (MDS) with an IPSS score >2.5
  • CML blast crisis
  • Relapsed or refractory acute myeloid leukemia (AML)
  • Neoplasms
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms