Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Jonsson Comprehensive Cancer Center
With
OBJECTIVES: Primary * Determine the antitumor activity of ABI-007 in patients with inoperable locally recurrent or metastatic melanoma. * Determine the safety and tolerability of this drug in these patients. Secondary * Determine the time to disease progression, in terms of the rate and duration of response or stable disease, in patients treated with this drug. * Determine the survival of patients treated with this drug. * Determine the effects of this drug on biomarkers of melanoma in these patients. * Correlate biomarker levels with response in patients treated with this drug. OUTLINE: This is an open-label, multicenter study. Patients are assigned to 1 of 2 treatment cohorts according to prior cytotoxic chemotherapy (previously treated vs chemotherapy-naïve). * Cohort I (previously treated): Patients receive ABI-007 IV over 30 minutes on days 1, 8, and 15. * Cohort II (chemotherapy-naïve): Patients receive a higher dose of ABI-007 as in cohort I. In both cohorts, courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 6 months and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 24-70 patients (12-35 per cohort) will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
