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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02773732
Recruitment Status : Recruiting
First Posted : May 16, 2016
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Leukemia Acute Myelogenous Leukemia Acute Myeloid Leukemia Drug: Ciprofloxacin Drug: Etoposide Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Ciprofloxacin and Etoposide Drug: Ciprofloxacin

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

Drug: Etoposide
Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
Other Names:
  • VP-16
  • Vepesid




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Measure the response duration following treatment with oral ciprofloxacin in combination with oral etoposide for the treatment of resistant AML. [ Time Frame: 24 months ]
  2. Measure progression-free survival following treatment with oral ciprofloxacin in combination with oral Etoposide for the treatment of resistant AML. [ Time Frame: 24 months ]
  3. Measure overall survival following treatment with oral ciprofloxacin in combination with oral Etoposide for the treatment of resistant AML. [ Time Frame: 24 months ]
  4. Estimate the incidence of Grade ≥ 3 adverse events following treatment with oral ciprofloxacin and oral etoposide at the MTD. [ Time Frame: 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of AML confirmed by review of bone marrow pathology at the University of Florida.
  • Patients with relapsed and /or refractory AML who: failed to achieve complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after at least one cycle of induction chemotherapy and not suitable for a second cycle of standard intensive chemotherapy; or who have progressed after 1 cycle of hypomethylating agent or intolerant to hypomethylating agent therapy and not suitable for standard induction chemotherapy regimens; or have 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.

Exclusion Criteria:

  • History of allergic or significant adverse reaction [e.g., anaphylaxis, prolonged QTc, or severe tendonitis] to ciprofloxacin or etoposide.
  • Acute promyelocytic leukemia (APL) with t(15;17).
  • Prolonged baseline QTc, defined as QTc interval > 470 msec in women and > 450 msec in men, or > 480 msec in subjects with a bundle branch block.
  • Uncontrolled, clinically significant infection. Subjects with a fever (temperature >= 38.3) thought to be related to leukemia are eligible assuming that blood cultures are negative during the 7 days prior to Cycle 1 Day 1 and there is no clinical evidence of active infection (e.g., negative or stable radiographs and negative physical examination).
  • Ongoing, symptomatic Clostridium difficile infection. Subjects who are asymptomatic with negative stool for C. difficile may participate.
  • Pregnant and or nursing.
  • History of Myasthenia Gravis.
  • Treatment with any anticancer therapy (standard or investigational) within 14 days prior to the first dose of ciprofloxacin or less than full recovery from the clinically significant toxic effects of that treatment. The use of hydroxyurea is allowed only during the first 14 days of Cycle 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773732


Contacts
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Contact: Erin Monari, PhD (352) 273-8128 PMO@cancer.ufl.edu

Locations
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United States, Florida
UF Health Shands Cancer Hospital Recruiting
Gainesville, Florida, United States, 32608
Contact: Christina Cline, RN    352-273-6840    clcline@ufl.edu   
Principal Investigator: Randall Brown, MD         
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Randall Brown, MD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02773732    
Other Study ID Numbers: IRB201600693
UF-AML-CE-101 ( Other Identifier: University of Florida )
OCR14651 ( Other Identifier: OF OnCore )
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Ciprofloxacin
Etoposide
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors