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Trial record 52 of 1189 for:    Oral Cancer | ( Map: Canada )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00963495
Recruitment Status : Terminated
First Posted : August 21, 2009
Last Update Posted : June 22, 2015
Information provided by (Responsible Party):
University Health Network, Toronto

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 hematologic malignancies. The study will also characterize Cliquinol's safety, tolerability and pharmacodynamic effect.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Myelodysplasia Lymphoma, Non-Hodgkin Hodgkin's Lymphoma Multiple Myeloma Drug: Clioquinol Phase 1

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study Evaluating the Tolerance and Biological Activity of Oral Clioquinol in Patients With Relapsed or Refractory Hematological Malignancy
Study Start Date : August 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: Clioquinol
Patients will take Clioquniol at various doses depending on which dose level they come into the study at. Once a MTD has been determined, the new patients that enter into the trial will then take it at that level.
Drug: Clioquinol
Patients will take Clioquniol at escalating doses depending on when they enter into the trial.

Primary Outcome Measures :
  1. 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. [ Time Frame: Varies ]

Secondary Outcome Measures :
  1. To determine the pharmacodynamic effects of Clioquinol on activity of the proteasome and relationship to the steady-state plasma concentrations of Cliquinol following multiple dosing, and to determine the response rate of Cliquinol. [ Time Frame: Varies ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
    • 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 nickel.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00963495

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Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Mark Minden, MD Princess Margaret Hospital, Canada

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Responsible Party: University Health Network, Toronto Identifier: NCT00963495    
Other Study ID Numbers: ADS1.0
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015
Keywords provided by University Health Network, Toronto:
relapsed and refractory hematologic malignancy
High risk myelodysplasia (MDS) with an IPSS score >2.5
CML blast crisis
Relapsed or refractory acute myeloid leukemia (AML)
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Leukemia, Myeloid, Acute
Multiple Myeloma
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Myeloid
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Leukemia, B-Cell
Bone Marrow Diseases
Precancerous Conditions