A Phase Ib/II Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects with Resistant Acute Myeloid Leukemia (AML)

Purpose

The purpose of the first part of this study is to establish the maximum tolerated dose (MTD) of oral ciprofloxacin when given in combination with a fixed dose of oral etoposide in patients with resistant acute myeloid leukemia (AML). The purpose of the second part of this study is to determine if the established dose of oral ciprofloxacin in combination with oral etoposide is effective in the treatment of patients with resistant AML.

Study details

This study will look at: any side effects that occur, the effectiveness of the study drug, and how your disease reacts to ciprofloxacin in combination with etoposide. This study will try to find the highest tolerated dose of ciprofloxacin without causing serious side effects.

This study will also look to see how your AML responds to the drugs using laboratory tests. Ciprofloxacin is a commonly used antibiotic drug that is approved for use by the United States Food and Drug Administration (FDA). The FDA has not approved ciprofloxacin to treat AML. Etoposide is an anticancer chemotherapy drug that is approved for use by the FDA for the treatment of small cell lung cancer and testicular cancer. Etoposide is also used for treatment of various blood cancers.

There is laboratory research that has shown that ciprofloxacin can make leukemia cells more sensitive to etoposide chemotherapy. This observation indicates that ciprofloxacin may help improve the effectiveness of etoposide in the treatment of resistant AML.

Eligibility

  • Ages 18 years old and older.
  • Diagnosis of AML confirmed by review of bone marrow pathology at the University of Florida.
  • Failure to achieve complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after at least 2 cycles of induction chemotherapy, or has relapsed after any duration of response.
  • Per the treating physician, the subject must have a life expectancy of >= 4 weeks.
  • Subject performance status must be Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2.
  • Subject must have a total bilirubin <= 2 mg/dL and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 times the upper limit of normal.
  • Subject must have serum creatinine < 2 mg/dL.
  • Females of child-bearing potential may participate, provided they meet the following conditions: Must agree to use physician-approved contraceptive methods throughout the study and for 6 months following the last dose of ciprofloxacin and/or etoposide; Must have a negative serum pregnancy test within 7 days prior to beginning treatment on this study.
  • Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods throughout the study and should avoid conceiving children for 6 months following the last dose of ciprofloxacin and/or etoposide.
  • Must provide written informed consent and be willing to comply with all study-related procedures.

Contact

For study details and questions, please contact Alina Thompson:

Age

18 to 65
65 and over

Gender

Male
Female

Keywords

Resistant Acute Myeloid Leukemia (AML), Oral Ciprofloxacin, maximum tolerated dose, complete remission

Principal Investigator

Randy A Brown, M.D.

Department

MD-HEMATOLOGY/ONCOLOGY

Contact Information

a.thompson@ufl.edu

352-273-6841


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