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A phase II study of ixabepilone (BMS-247550) in metastatic renal-cell carcinoma
Edwin M Posadas1, Samir Undevia, Elizabeth Manchen
1University of Chicago Phase II Consortium, Section of Hematology/Oncology, Chicago, Illinois 60637, USA. eposadas@medicine.bsd.uchicago.edu
Introduction:
Ixabepilone (BMS-247550) is a semi-synthetic analog of epothilone B that has been characterized as a microtubule stabilizing agent with a mechanism of action distinct from taxanes. Suggestion of activity in renal cell carcinoma (RCC) has been seen in early clinical studies.
Methods:
Eligible patients had metastatic RCC as well as ECOG performance status 0-2 and normal organ function. Patients received ixabepilone at a dose of 40 mg/m2 intravenously over three hours every 21 days. There was no restriction on RCC histology or prior treatment type, but prior treatment with tubule inhibitors was not allowed. The primary endpoint was RECIST defined response and radiographic evaluations were performed every three cycles. Toxicity evaluations utilized CTCAE v3.0 and were performed every cycle. Using a Simon two-stage optimal design with alpha = 0.1, beta = 0.1, a null hypothesized response rate of 0.05 and an alternative response rate of 0.2, an initial 12 patients were to be accrued with full accrual of 37 patients if at least one response were observed.
Results:
A median of five cycles were administered. No objective responses were observed in the first 12 evaluable patients, and six patients showed stable disease for more than 18 weeks on therapy. Median time to progression among those with objective progression was nine weeks. One patient experienced grade 4 anemia and lymphopenia. Grade 3 adverse events included lymphopenia, neutropenia, leukopenia, diarrhea, and infection. Common grade 2 toxicities included alopecia, fatigue and anemia.
Conclusion:
Ixabepilone administered at a dose of 40 mg/m2 every 21 days should not be advanced for further study in metastatic RCC. Given previous results, however, other dosing schedules may be worthy of further investigation.
Insights
Ixabepilone did not show efficacy in metastatic renal cell carcinoma (RCC) at the tested dose. Further investigation into different dosing schedules for ixabepilone in RCC may be warranted.
Area of Science:
- Oncology
- Pharmacology
Background:
- Ixabepilone is a microtubule stabilizing agent with a distinct mechanism from taxanes.
- Early studies suggested potential activity of ixabepilone in renal cell carcinoma (RCC).
Purpose of the Study:
- To evaluate the efficacy and safety of ixabepilone in patients with metastatic RCC.
- To determine if ixabepilone warrants further investigation in metastatic RCC.
Main Methods:
- A phase II clinical trial was conducted with patients who had metastatic RCC.
- Patients received ixabepilone at 40 mg/m2 intravenously every 21 days.
- The primary endpoint was RECIST-defined response rate, with toxicity assessed using CTCAE v3.0.
Main Results:
- No objective responses were observed in the first 12 evaluable patients.
- Six patients achieved stable disease for over 18 weeks.
- Grade 3/4 toxicities included anemia, lymphopenia, neutropenia, leukopenia, diarrhea, and infection.
Conclusions:
- Ixabepilone at 40 mg/m2 every 21 days is not recommended for further study in metastatic RCC.
- Alternative dosing schedules for ixabepilone may merit further investigation in RCC based on prior findings.
