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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
88
New York University Clinical Cancer Center
New York, New York, United States
Response rate
The 95% confidence intervals will be provided.
Time frame: Up to 2 years
Median time to progression
Median time to progression will be described for each subgroup.
Time frame: 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.
Time frame: Up to 2 years
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