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.
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
Drug | Synonyms | Arms |
---|
Ciprofloxacin | Cipro | Ciprofloxacin and Etoposide |
Etoposide | VP-16, Vepesid | Ciprofloxacin 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.
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
Name | Type | Description | Interventions |
---|
Ciprofloxacin and Etoposide | Experimental | | |
Eligibility 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.
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: | Active, not recruiting |
Lead Sponsor: | University of Florida |
Last Updated
August 17, 2021