NCT00963495

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia
• Acute Lymphocytic Leukemia
• Chronic Lymphocytic Leukemia
• Myelodysplasia
• Lymphoma, Non-Hodgkin
• Hodgkin's Lymphoma
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Clioquinol	Patients will take Clioquniol at escalating doses depending on when they enter into the trial.

Timeline

• Start date: 2009-08-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2009-08-21
• Last updated: 2015-06-22

Locations

1 site across 1 country: Canada