BMS-247550 in Treating Patients With Stage IV Melanoma

Study Overview
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Brief Summary
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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

Detailed Description
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OBJECTIVES: I. Determine the efficacy of BMS-247550 in patients with stage IV melanoma. II. Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to the number of prior chemotherapy regimens (0 vs 1-2, including dacarbazine or temozolomide). 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.

Official Title
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A Phase II Study Of Epothilone B Analog BMS 247550 (NSC # 710428) In Stage IV Malignant Melanoma

Conditions
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Recurrent Melanoma, Stage IV Melanoma

Intervention / Treatment
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* Drug: ixabepilone
* Other: pharmacogenomic studies
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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. | Drug: ixabepilone<br>* Given IV<br>* Other names: Ixempra;Other: pharmacogenomic studies<br>* Correlative studies<br>* Other names: Pharmacogenomic Study;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | The 95% confidence intervals will be provided. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median time to progression | Median time to progression will be described for each subgroup. | Time from the first day of treatment with BMS 247550 until the first documentation of disease progression, assessed up to 2 years | 
| Incidence of related toxicities graded according to the revised NCI CTC version 2.0 | Related toxicities will be described. | Up to 2 years |