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Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML)(UF-AML-CE-101)
Phase 1, PHASE2 trial testing Ciprofloxacin 750 MG in Leukemia in 11 participants. Terminated before completion.
| Lead sponsor | University of Florida |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 16 December 2016 |
| Primary completion | 7 September 2021 |
| Estimated completion | 15 November 2021 |
| Sites | 1 location across United States |
University of Florida
18 and older, any sex, with Leukemia or Acute Myelogenous Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Ciprofloxacin and Etoposide | 1000 |
Measure the response duration following treatment with oral ciprofloxacin in combination with oral etoposide for the treatment of resistant AML.
| Group | Value | 95% CI |
|---|---|---|
| Ciprofloxacin Dose Level +1 | 111 |
Measure progression-free survival following treatment with oral ciprofloxacin in combination with oral Etoposide for the treatment of resistant AML.
| Group | Value | 95% CI |
|---|---|---|
| Ciprofloxacin Dose Level 0 | 56 | 25 – 115 |
| Ciprofloxacin Dose Level +1 | 92.25 | 26 – 317 |
Measure overall survival following treatment with oral ciprofloxacin in combination with oral Etoposide for the treatment of resistant AML.
| Group | Value | 95% CI |
|---|---|---|
| Ciprofloxacin Dose Level 0 | 140.67 | 25 – 282 |
| Ciprofloxacin Dose Level +1 | 109.29 | 43 – 317 |
Estimate the rate of Grade ≥ 3 adverse events following treatment with oral ciprofloxacin and oral etoposide at the MTD.
| Group | Value | 95% CI |
|---|---|---|
| Ciprofloxacin Dose Level 0 | 20 | |
| Ciprofloxacin Dose Level +1 | 28.45 |
Time frame: At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Ciprofloxacin Dose Level 0 | Ciprofloxacin Dose Level +1 |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Fever | General disorders | — | — |
| Cardiac disorders - other, specify | Cardiac disorders | — | — |
| Metabolism and nutrition disorders - other, specify | Metabolism and nutrition disorders | — | — |
| Encephalopathy | Nervous system disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Reaction | System | Ciprofloxacin Dose Level 0 | Ciprofloxacin Dose Level +1 |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — |
| Platelet count decreased | Investigations | — | — |
| White blood cell decreased | Investigations | — | — |
| Creatinine increased | Investigations | — | — |
| Fatigue | General disorders | — | — |
| Hyperuricemia | Metabolism and nutrition disorders | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Lung infection | Infections and infestations | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Skin ulceration | Skin and subcutaneous tissue disorders | — | — |
| Urinary frequency | Renal and urinary disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Alkaline phosphatase increased | Investigations | — | — |
| Cardiac disorders - other, specify | Cardiac disorders | — | — |
| Chills | General disorders | — | — |
| Confusion | Psychiatric disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Febrile neutropenia, Abdominal pain, Fever, Cardiac disorders - other, specify, Metabolism and nutrition disorders - other, specify, Encephalopathy, Diarrhea, Dehydration.
Data from ClinicalTrials.gov NCT02773732 adverse events section.
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.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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