BMS-247550 in Treating Patients With Stage IV Melanoma
BMS-247550 in Treating Patients With Stage IV Melanoma
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.
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