RATIONALE: Drugs used in chemotherapy, such as everolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may also stop the growth of melanoma by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with stage IV melanoma.
OBJECTIVES: Primary * Determine the median time to disease progression in patients with stage IV malignant melanoma treated with everolimus. Secondary * Determine the median overall survival of patients treated with this drug. * Determine the clinical benefit rates (i.e., stable disease, partial remission, and complete response rates) in patients treated with this drug. * Determine the toxicity profile of this drug in these patients. * Determine changes in serum vascular endothelial growth factor levels in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral everolimus once daily for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months until disease progression and then every 4 months for up to 5 years after registration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Proportion of patients with progression-free disease at 16 weeks
Time frame: at 16 weeks
Median overall survival
Time frame: Up to 5 years
Tumor response rate for 2 consecutive evaluations at least 8 weeks apart
Time frame: Up to 5 years
Toxicity as measured by CTCAE v. 3.0
Time frame: Up to 5 years
disease progression
Time frame: at 16 weeks
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