BMS-247550 in Treating Patients With Stage IV Melanoma

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.

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