Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML)(UF-AML-CE-101)
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|ClinicalTrials.gov Identifier: NCT02773732|
Recruitment Status : Recruiting
First Posted : May 16, 2016
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Acute Myelogenous Leukemia Acute Myeloid Leukemia||Drug: Ciprofloxacin Drug: Etoposide||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/II Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML)|
|Actual Study Start Date :||December 16, 2016|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
|Experimental: Ciprofloxacin and Etoposide||
Ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Dose Level 0 Ciprofloxacin 750 mg Dose Level +1 Ciprofloxacin 1000 mg Dose Level -1 Ciprofloxacin 500 mg
Other Name: Cipro
Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
- Establish the maximum tolerated dose (MTD) of oral ciprofloxacin when given in combination with a fixed dose of oral Etoposide for the treatment of resistant AML. [ Time Frame: 1 month ]
- Determine the rate of complete remission (CR) following treatment with the MTD of oral ciprofloxacin in combination with oral Etoposide for the treatment of resistant AML. [ Time Frame: 24 months ]
- Measure the response duration following treatment with oral ciprofloxacin in combination with oral etoposide for the treatment of resistant AML. [ Time Frame: 24 months ]
- Measure progression-free survival following treatment with oral ciprofloxacin in combination with oral Etoposide for the treatment of resistant AML. [ Time Frame: 24 months ]
- Measure overall survival following treatment with oral ciprofloxacin in combination with oral Etoposide for the treatment of resistant AML. [ Time Frame: 24 months ]
- Estimate the incidence of Grade ≥ 3 adverse events following treatment with oral ciprofloxacin and oral etoposide at the MTD. [ Time Frame: 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773732
|Contact: Erin Monari, PhD||(352) 273-8128||PMO@cancer.ufl.edu|
|United States, Florida|
|UF Health Shands Cancer Hospital||Recruiting|
|Gainesville, Florida, United States, 32608|
|Contact: Christina Cline, RN 352-273-6840 email@example.com|
|Principal Investigator: Randall Brown, MD|
|Principal Investigator:||Randall Brown, MD||University of Florida|