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Patients will take Ciclopirox Olamine at escalating doses depending on when they enter into the trial.

Patients will take Ciclopirox Olamine at various doses depending on which dose level they come into the study at. Ciclopirox olamine will be administered orally as an aqueous suspension without food. The starting dose will be 5 mg/m2/day administered as a single dose daily for 5 days (one cycle). Once a MTD has been determined, the new patients that enter into the trial will then take it at that level.

Ciclopirox Olamine

Mark Minden, MD

This is an open-label, single arm study. Approximately 3-30 patients will be enrolled. Patients will receive Oral ciclopirox olamine (aqueous suspension), initial starting dose of 5 mg/m2/day administered as a single dose daily for 5 days. Three patients will initially be treated at each dose level in sequential cohorts. Dose escalation will continue for each subsequent cohort based on toxicity and plasma drug concentrations observed during the previous cohort. Dose escalation will continue until establishment of the maximum tolerated dose (MTD) has been met.

Patients who have demonstrated response to treatment, up to 6 total cycles of treatment may be administered. If additional cycles are warranted, ciclopirox olamine will be given at the same dose and frequency as the patient initially received.

Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy

Phase 1 Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy

The Leukemia and Lymphoma Society

University Health Network, Toronto

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy	NCT00990587	Hematologic Mal... Acute Lymphocyt... Chronic Lymphoc... Myelodysplasia Acute Myeloid L... Chronic Myeloge... Hodgkin's Disea...	Ciclopirox Olam...	18 Years -	University Health Network, Toronto
Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy	NCT00990587	Hematologic Mal... Acute Lymphocyt... Chronic Lymphoc... Myelodysplasia Acute Myeloid L... Chronic Myeloge... Hodgkin's Disea...	Ciclopirox Olam...	18 Years -	University Health Network, Toronto

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