LeukemiaPhase 1/2NCT02773732
Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML)(UF-AML-CE-101)
A Phase 1/2 study testing Ciprofloxacin 750 MG, Etoposide and Ciprofloxacin 1000 MG in people with Leukemia and Acute Myelogenous Leukemia, run by University of Florida at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Acute Myelogenous Leukemia, Acute Myeloid Leukemia
- What is being tested?
- Ciprofloxacin 750 MG, Etoposide and Ciprofloxacin 1000 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2016to 15 Nov 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Shands Cancer Hospital
Gainesville, Florida, 32608
About this study
Official title: A Phase Ib/II Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML)
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.
Read the 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
- Being tested
- Ciprofloxacin 750 MG, Etoposide, Ciprofloxacin 1000 MG, Ciprofloxacin 500 mg
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin 750 MGDrug
Also called Cipro
750 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
EtoposideDrug
Also called VP-16, Vepesid
Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
Ciprofloxacin 1000 MGDrug
Also called Cipro
1000 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Ciprofloxacin 500 mgDrug
Also called Cipro
500 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin Dose Level 0 | Experimental | Not described Receives: Drug: Ciprofloxacin 750 MG; Drug: Etoposide |
| Ciprofloxacin Dose Level +1 | Experimental | Not described Receives: Drug: Etoposide; Drug: Ciprofloxacin 1000 MG |
| Ciprofloxacin Dose Level -1 | Experimental | Not described Receives: Drug: Etoposide; Drug: Ciprofloxacin 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
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.
Measured: 1 month
Rate of Complete Remission
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.
Measured: 0 months
Secondary outcomes (4)
Response Duration
Measure the response duration following treatment with oral ciprofloxacin in combination with oral etoposide for the treatment of resistant AML.
Measured: 111 days
Progression-free Survival
Measure progression-free survival following treatment with oral ciprofloxacin in combination with oral Etoposide for the treatment of resistant AML.
Measured: 317 days
Overall Survival
Measure overall survival following treatment with oral ciprofloxacin in combination with oral Etoposide for the treatment of resistant AML.
Measured: 317 days
Percentage of Grade ≥ 3 Adverse Events
Estimate the rate of Grade ≥ 3 adverse events following treatment with oral ciprofloxacin and oral etoposide at the MTD.
Measured: 93 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study start16 Dec 2016
- Primary completion7 Sep 2021
- Study completion15 Nov 2021
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randall Brown, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773732
- Sponsor's protocol ID
- IRB201600693
- Other IDs
- UF-AML-CE-101, OCR14651
- Status last verified
- Jul 2022
- First submitted
- 12 May 2016
- Last updated
- 5 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gera K, Cline C, Al-Mansour Z, Medvec A, Lee JH, Galochkina Z, Hsu J, Hiemenz J, Farhadfar N, Dean EA, Wingard JR, Brown R. A phase ib clinical trial of oral ciprofloxacin and etoposide in subjects with resistant acute myeloid leukemia. Leuk Lymphoma. 2024 Oct;65(10):1502-1510. doi: 10.1080/10428194.2024.2361111. Epub 2024 Jun 6.
PubMed 38841781
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT02773732
- Acronym / sponsor ID
- IRB201600693
- Conditions
- Leukemia, Acute Myelogenous Leukemia, Acute Myeloid Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Posted 5 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin Dose Level 0 | Experimental | Drug: Ciprofloxacin 750 MG, Drug: Etoposide |
| Ciprofloxacin Dose Level +1 | Experimental | Drug: Etoposide, Drug: Ciprofloxacin 1000 MG |
| Ciprofloxacin Dose Level -1 | Experimental | Drug: Etoposide, Drug: Ciprofloxacin 500 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciprofloxacin 750 MGAlso: Cipro750 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle. | Drug | Ciprofloxacin Dose Level 0 |
| EtoposideAlso: VP-16, VepesidEtoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle. | Drug | Ciprofloxacin Dose Level +1, Ciprofloxacin Dose Level -1, Ciprofloxacin Dose Level 0 |
| Ciprofloxacin 1000 MGAlso: Cipro1000 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle. | Drug | Ciprofloxacin Dose Level +1 |
| Ciprofloxacin 500 mgAlso: Cipro500 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle. | Drug | Ciprofloxacin Dose Level -1 |
Primary outcome
Maximum Tolerated Dose
Time frame: 1 month
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.
Rate of Complete Remission
Time frame: 0 months
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.
4 secondary outcomes
Response Duration
Time frame: 111 days
Progression-free Survival
Time frame: 317 days
Overall Survival
Time frame: 317 days
Percentage of Grade ≥ 3 Adverse Events
Time frame: 93 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38841781Gera K, Cline C, Al-Mansour Z, Medvec A, Lee JH, Galochkina Z, Hsu J, Hiemenz J, Farhadfar N, Dean EA, Wingard JR, Brown R. A phase ib clinical trial of oral ciprofloxacin and etoposide in subjects with resistant acute myeloid leukemia. Leuk Lymphoma. 2024 Oct;65(10):1502-1510. doi: 10.1080/10428194.2024.2361111. Epub 2024 Jun 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall Brown, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ciprofloxacin 750 MG, Etoposide and Ciprofloxacin 1000 MG in people with Leukemia and Acute Myelogenous Leukemia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02773732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.