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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00963495
First received: August 19, 2009
Last updated: January 17, 2011
Last verified: January 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: August 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963495

Contacts
Contact: Skeeta Sobrian-Couroux 416-946-4501 ext 4155 Skeeta.Sobrian-Couroux@uhn.on.ca

Locations
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Skeeta Sobrian-Couroux    416-946-4501 ext 4155    Skeeta.Sobrian-Couroux@uhn.on.ca   
Principal Investigator: Mark Minden, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Mark Minden, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

Responsible Party: Dr. Aaron Shimmer, University Health Network, Princess Margaret Hospital
ClinicalTrials.gov Identifier: NCT00963495     History of Changes
Other Study ID Numbers: ADS1.0
Study First Received: August 19, 2009
Last Updated: January 17, 2011
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
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)

Additional relevant MeSH terms:
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
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on July 28, 2014