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

Phase 1
18 Years
Open (Enrolling)
Hematologic Malignancy, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Myelodysplasia, Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, Hodgkin's Disease

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Trial Information

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

Inclusion Criteria:

1. Age > 18

2. Relapsed or refractory hematologic malignancies including AML, ALL, CLL, high risk
myelodysplasia (International Prognostic Score >2.5), CML blast crisis, multiple
myeloma, non-Hodgkin's lymphoma, and Hodgkin's lymphoma for which all potentially
curative therapy options have been exhausted.

3. ECOG (Eastern Cooperative Oncology Group) performance status < 2.

4. Biochemical values within the following range:

1. Serum creatinine < 2x upper limit of normal.

2. Total bilirubin < 2x upper limit of normal, AST (asparatate aminotransferase)
and ALT (alanine aminotransferase) < 5x upper limit of normal.

5. Ability to maintain adequate oral intake of medication.

6. Ability to understand and sign informed consent.

7. Toxicity from prior chemotherapy has resolved

Exclusion Criteria:

1. Uncontrolled systemic infection.

2. Uncontrolled intercurrent illness

3. Pregnant or breast feeding

4. Active CNS (central nervous system) 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 ciclopirox

8. Concurrent therapy with topical ciclopirox olamine.

9. Use of other investigational anti-cancer therapy within two weeks of study entry.

10. Use of oral or intravenous metal supplements including iron, copper, zinc and nickel.

11. Resting ejection fraction < 50%

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of ciclopirox olamine.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Mark Minden, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada


Canada: Health Canada

Study ID:

CPX V001



Start Date:

October 2009

Completion Date:

October 2013

Related Keywords:

  • Hematologic Malignancy
  • Acute Lymphocytic Leukemia
  • Chronic Lymphocytic Leukemia
  • Myelodysplasia
  • Acute Myeloid Leukemia
  • Chronic Myelogenous Leukemia
  • Hodgkin's Disease
  • relapsed and refractory hematologic malignancy
  • ALL (acute lymphoid leukemia)
  • CLL (chronic lymphoid leukemia)
  • High risk myelodysplasia (MDS) with an IPSS (International Prognostic Scoring System) score >2.5
  • CML (chronic myelogenous leukemia) blast crisis
  • Relapsed or refractory acute myeloid leukemia (AML)
  • Neoplasms
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms