NCT02773732

Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML)(UF-AML-CE-101)

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. 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.

Conditions

• Leukemia
• Acute Myelogenous Leukemia
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Ciprofloxacin 750 MG	750 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
DRUG	Etoposide	Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
DRUG	Ciprofloxacin 1000 MG	1000 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
DRUG	Ciprofloxacin 500 mg	500 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.

Timeline

• Start date: 2016-12-16
• Primary completion: 2021-09-07
• Completion: 2021-11-15
• First posted: 2016-05-16
• Last updated: 2022-08-05
• Results posted: 2022-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study