Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic malignant melanoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
OBJECTIVES: I. Determine the progression-free survival at 18 weeks and overall survival of patients with metastatic malignant melanoma treated with PS-341. II. Determine the objective response rate of patients treated with this drug. III. Correlate p27 levels in tumor tissue with objective response rate in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive PS-341 IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3-6 months for up to 2 years after registration. PROJECTED ACCRUAL: A total of 22-50 patients will be accrued for this study within 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Given IV
Correlative studies
Mayo Clinic
Rochester, Minnesota, United States
Proportion of patients who are progression-free
Confidence intervals for the true success proportion will be calculated.
Time frame: 18 weeks
Objective response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) in terms of tumor/lesion size and change
Time frame: Up to 2 years
Overall survival
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time frame: Time from registration to death due to any cause, assessed up to 2 years
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