BMS-247550 in Treating Patients With Stage IV Melanoma

• Median time to progression [ Time Frame: Time from the first day of treatment with BMS 247550 until the first documentation of disease progression, assessed up to 2 years ] [ Designated as safety issue: No ]
  Median time to progression will be described for each subgroup.
• Incidence of related toxicities graded according to the revised NCI CTC version 2.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  Related toxicities will be described.

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

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.

• Recurrent Melanoma
• Stage IV Melanoma

• Drug: ixabepilone
  Given IV
  Other Names:

  • BMS-247550
  • epothilone B lactam
  • Ixempra
• Other: pharmacogenomic studies
  Correlative studies
  Other Name: Pharmacogenomic Study
• Other: laboratory biomarker analysis
  Correlative studies

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