Clinical trial · Interventional
BMS-247550 in Treating Patients With Stage IV Melanoma
A Phase II Study Of Epothilone B Analog BMS 247550 (NSC # 710428) In Stage IV Malignant Melanoma
NCT00036764CI-TRIAL-00009141completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase II trial to study the effectiveness of BMS-247550 in treating patients who have stage IV melanoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ixabepilone | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacogenomic studies | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Patients receive BMS-247550 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: ixabepilone
- Other: pharmacogenomic studies
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Up to 2 years
- description
- The 95% confidence intervals will be provided.
Secondary outcomes (2)
- measure
- Median time to progression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed stage IV melanoma * At least 1 measurable lesion * Greater than 20 mm by conventional techniques * Greater than 10 mm by spiral CT scan * Known brain metastases allowed if all of the following criteria are met: * Radiologically stable for at least 6 weeks after completion of whole brain radiotherapy * Stable at time of study * No mass effect present radiologically * No concurrent steroids to control symptoms of brain metastases * Performance status - ECOG 0-2 * Performance status - Karnofsky 60-100% * At least 3 months * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin normal * AST/ALT no greater than 2.5 times upper limit of normal (ULN) * Creatinine no greater than 1.5 times ULN * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior severe allergic reactions (grade III or IV or grade II not responsive to steroids) to taxanes or medications containing Cremophor EL * No pre-existing grade 2 or greater peripheral neuropathy * No HIV-positive patients receiving combination antiretroviral therapy * No other concurrent uncontrolled illness * No ongoing or active infection * No psychiatric illness that would preclude study * Prior vaccine therapy allowed * Prior immunotherapy (e.g., interleukin-2 or interferon) allowed * Stratum I: * No prior chemotherapy * Stratum II: * No more than 2 prior chemotherapy regimens (must have included dacarbazine or temozolomide) * See Disease Characteristics * See Disease Characteristics * Prior limb-perfusion therapy allowed (stratum II) * No other concurrent investigational or commercial agents or therapies intended to treat malignancy * No concurrent Hypericum perforatum
References
Publications (1)
- DERIVEDOtt PA, Hamilton A, Jones A, Haas N, Shore T, Liddell S, Christos PJ, Doyle LA, Millward M, Muggia FM, Pavlick AC. A phase II trial of the epothilone B analog ixabepilone (BMS-247550) in patients with metastatic melanoma. PLoS One. 2010 Jan 20;5(1):e8714. doi: 10.1371/journal.pone.0008714. PMID 20098694