Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00963495
Recruitment Status : Terminated
First Posted : August 21, 2009
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE August 19, 2009
First Posted Date  ICMJE August 21, 2009
Last Update Posted Date June 22, 2015
Study Start Date  ICMJE August 2009
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00963495 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Tolerance and Biological Activity of Oral Clioquinol in Patients With Relapsed or Refractory Hematological Malignancy
Official Title  ICMJE Phase 1 Study Evaluating the Tolerance and Biological Activity of Oral Clioquinol in Patients With Relapsed or Refractory Hematological Malignancy
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myeloid Leukemia
  • Acute Lymphocytic Leukemia
  • Chronic Lymphocytic Leukemia
  • Myelodysplasia
  • Lymphoma, Non-Hodgkin
  • Hodgkin's Lymphoma
  • Multiple Myeloma
Intervention  ICMJE Drug: Clioquinol
Patients will take Clioquniol at escalating doses depending on when they enter into the trial.
Study Arms  ICMJE 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.
Intervention: Drug: Clioquinol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 19, 2015)
11
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2009)
48
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00963495
Other Study ID Numbers  ICMJE ADS1.0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Minden, MD Princess Margaret Hospital, Canada
PRS Account University Health Network, Toronto
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP