OBJECTIVES:

• Determine the efficacy of BMS-247550 in patients with stage IV melanoma.
• 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.

PROJECTED ACCRUAL: A total of 23-88 patients (11-50 who have not received prior chemotherapy and 12-38 who have received prior chemotherapy) will be accrued for this study within 24 months.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage IV melanoma

• At least 1 measurable lesion

  • Greater than 20 mm by conventional techniques OR
  • 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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2 OR
• Karnofsky 60-100%

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin normal
• AST/ALT no greater than 2.5 times upper limit of normal (ULN)

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other:

• 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 CONCURRENT THERAPY:

Biologic therapy:

• Prior vaccine therapy allowed
• Prior immunotherapy (e.g., interleukin-2 or interferon) allowed

Chemotherapy:

• Stratum I:

  • No prior chemotherapy

• Stratum II:

  • No more than 2 prior chemotherapy regimens (must have included dacarbazine or temozolomide)

Endocrine therapy:

• See Disease Characteristics

Radiotherapy:

• See Disease Characteristics

Surgery:

• Not specified

Other:

• Prior limb-perfusion therapy allowed (stratum II)
• No other concurrent investigational or commercial agents or therapies intended to treat malignancy
• No concurrent Hypericum perforatum