Finding studies
Finding studies
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Lead
University of Medicine and Dentistry of New Jersey
With
OBJECTIVES: * The primary objective of this study is to assess the antitumor activity, measured by tumor response rate, in patients who receive this regimen as a third-line treatment. (Phase II) Secondary * To measure the duration of response for responding patients. * To measure the time to progressive disease. * To measure survival time. * To characterize the quantitative and qualitative toxicities of this regimen in these patients. * To develop pharmacodynamic markers for autophagy detection in patient specimens. * To characterize the effects of hydroxychloroquine on autophagy in patients in vivo. * To investigate whether the estrogen receptor, progesterone receptor, and/or HER2 status of breast tumors correlates with treatment response. OUTLINE: This is a multicenter, phase I dose-escalation study of ixabepilone followed by a phase II study. During the first course, patients receive ixabepilone IV over 3 hours on day 1 and oral hydroxychloroquine twice daily on days 3-21. On all subsequent courses, patients receive ixabepilone IV over 3 hours on day 1 and oral hydroxychloroquine twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 6 months.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
