Actively Recruiting
Trial of Ixazomib for Kaposi Sarcoma
Led by AIDS Malignancy Consortium · Updated on 2026-02-27
41
Participants Needed
11
Research Sites
279 weeks
Total Duration
On this page
Sponsors
A
AIDS Malignancy Consortium
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial of Ixazomib for Kaposi Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willingness to sign a written informed consent document
- Histologically or cytologically confirmed cutaneous Kaposi sarcoma with measurable disease (at least five measurable skin lesions or total surface area >= 700 mm^2 if fewer than five lesions)
- Documentation of HIV status: negative with recent negative HIV test or confirmed HIV-1 infection
- Eastern Cooperative Oncology Group (ECOG) performance status <= 2 (Karnofsky >= 50%)
- Life expectancy greater than 3 months
- Absolute neutrophil count >= 1,000/mm^3 within 21 days before enrollment
- Hemoglobin > 8 g/dL within 21 days before enrollment
- Platelets >= 75,000/mm^3 within 21 days before enrollment (no platelet transfusions within 3 days before enrollment)
- Total bilirubin <= 1.5 times upper limit of normal within 21 days before enrollment, with exceptions for certain drug-related elevations
- Serum creatinine within normal limits or creatinine clearance >= 30 mL/min within 21 days before enrollment
- For participants with cardiac disease history, New York Heart Association Functional Classification class 2B or better within 6 months before enrollment
- Agreement to use adequate contraception during the study and for 90 days after treatment if of child-bearing potential or men
- If HIV positive, on stable antiretroviral therapy with optimal viral control for required durations and no recent KS improvement that may confound response
- At least 4 weeks since last KS-directed therapy with residual active lesions eligible if systemic therapy is warranted
You will not qualify if you...
- Receiving any other investigational agents
- History of allergic reactions to ixazomib or similar compounds
- Chronic systemic use of strong CYP3A inducers or St. John's wort without discontinuation 14 days before treatment
- Uncontrolled illness including active infection or unstable cardiovascular conditions
- Second prior or concurrent cancer that may interfere with study assessments
- Pregnancy or breastfeeding
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for some drugs) before study entry
- Residual toxicity from prior cancer therapy greater than grade 1, excluding hair loss
- Hepatitis B surface antigen positive or detectable hepatitis B DNA by PCR
- Hepatitis C positive with cirrhosis or abnormal liver function tests
- Gastrointestinal disease or procedures affecting oral absorption or tolerance of ixazomib
- Grade 2 or higher peripheral neuropathy at screening
- Major surgery within 14 days before enrollment
- Symptomatic visceral Kaposi sarcoma
- Prior proteasome inhibitor treatment for Kaposi sarcoma within 2 years or any prior ixazomib treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
UC San Diego
San Diego, California, United States, 92093
Actively Recruiting
2
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110
Actively Recruiting
3
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
4
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
5
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
6
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
8
Abramson Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19106
Actively Recruiting
9
Thomas Street Clinic
Houston, Texas, United States, 77004
Actively Recruiting
10
Thomas Street Clinic
Houston, Texas, United States, 77004
Actively Recruiting
11
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Actively Recruiting
Research Team
E
Erin Reid, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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