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Download A study for patients with AIDS-associated Kaposi`s sarcoma (KS
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A study for patients with AIDS-associated Kaposi’s sarcoma (KS) and HIV Single arm dose finding pilot trial of single agent bortezomib in patients with relapsed/refractory AIDS-associated Kaposi’s sarcoma with correlative assessments of KSHV and HIV (AMC 063) Study Design This is a pilot study of the drug bortezomib, given alone for Kaposi’s sarcoma (KS). Velcade has been approved by the Food and Drug Administration (FDA) to treat other types of cancers and relapsed nonHodgkin’s lymphoma. This study is being done to find out if bortezomib is a safe and effective treatment for AIDS associated KS. There will be 24 participants in this study nationwide. There will be about 4 participants at UCLA. Inclusion Criteria x x x x x HIV positive men and women, 18 years of age or older. Kaposi’s sarcoma that has been treated and has either come back or has not gone away At least 5 Kaposi’s sarcoma lesions on the skin that have not been treated with radiation On stable antiretroviral therapy for at least 12 weeks Ability to understand informed consent Exclusion Criteria x x x x x An active opportunistic infection Shingles outbreak within the last 6 months Another cancer within the last 5 years Pregnancy and breast feeding Active hepatitis B or C infection Principal Investigator: Ronald Mitsuyasu, MD For more information, call (310) 557-9062 Protocol ID:IRB#11-000137 UCLA IRB Approved Approval Date: 2/17/2012 Through: 1/3/2013 Committee: Medical IRB 2
