A Phase 2 Trial of Ixazomib for Kaposi Sarcoma
AIDS Malignancy Consortium
Summary
This phase II trial studies how well ixazomib works in treating patients with Kaposi sarcoma. Ixazomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Description
PRIMARY OBJECTIVE: I. Determine the overall response rate of ixazomib in participants with Kaposi sarcoma. SECONDARY OBJECTIVES: I. Determine safety and tolerability of ixazomib. II. Assess changes in Kaposi-sarcoma associated herpesvirus (KSHV) viral load (VL) by ixazomib. III. Correlate changes in KSHV VL with tumor response. IV. For human immunodeficiency virus (HIV)-positive participants, assess changes in CD4 counts and HIV viral load. EXPLORATORY OBJECTIVE: I. Assess changes in quality of life during ixazomib therapy. OUTLINE: Patients receive ixazomib orally (PO) on days 1, 8, a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document * Participants must have histologically or cytologically confirmed cutaneous Kaposi sarcoma. Participants must have measurable disease with a minimum of five bi-dimensionally measurable KS cutaneous marker lesions. If fewer than five bi-dimensionally measurable marker lesions are available, the total surface area of the marker lesion(s) must be \>= 700 mm\^2 * Participants must have documentation of HIV status. If HIV negative, documentation of a negative HIV rapid test within 21 days b…
Interventions
- DrugIxazomib Citrate
Given PO
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
Locations (11)
- UC San DiegoSan Diego, California
- Zuckerberg San Francisco General HospitalSan Francisco, California
- University of Miami Miller School of MedicineMiami, Florida
- University of Illinois Cancer CenterChicago, Illinois
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland
- Washington UniversitySt Louis, Missouri