Clinical Trials /

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

NCT02773732

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML)(UF-AML-CE-101)
  • Official Title: A Phase Ib/II Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML)

Clinical Trial IDs

  • ORG STUDY ID: IRB201600693
  • SECONDARY ID: UF-AML-CE-101
  • SECONDARY ID: OCR14651
  • NCT ID: NCT02773732

Conditions

  • Leukemia
  • Acute Myelogenous Leukemia
  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
CiprofloxacinCiproCiprofloxacin and Etoposide
EtoposideVP-16, VepesidCiprofloxacin and Etoposide

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.

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.
      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.
    

Trial Arms

NameTypeDescriptionInterventions
Ciprofloxacin and EtoposideExperimental
  • Ciprofloxacin
  • Etoposide

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  History of allergic or significant adverse reaction [e.g., anaphylaxis, prolonged QTc
             (corrected QT interval), 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Measure the response duration following treatment with oral ciprofloxacin in combination with oral etoposide for the treatment of resistant AML.
Time Frame:24 months
Safety Issue:
Description:
Measure:Measure progression-free survival following treatment with oral ciprofloxacin in combination with oral Etoposide for the treatment of resistant AML.
Time Frame:24 months
Safety Issue:
Description:
Measure:Measure overall survival following treatment with oral ciprofloxacin in combination with oral Etoposide for the treatment of resistant AML.
Time Frame:24 months
Safety Issue:
Description:
Measure:Estimate the incidence of Grade ≥ 3 adverse events following treatment with oral ciprofloxacin and oral etoposide at the MTD.
Time Frame:24 months
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Florida

Last Updated

December 19, 2019