About this trial
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.
Eligibility criteria
Qualifiers
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 mm²
Documentation of HIV diagnosis in the medical record by a licensed health care provider
Documentation of receipt of antiretroviral therapy (ART) (at least two different medications that do not constitute a prescription for pre exposure prophylaxis [PrEP]) by a licensed health care provider. Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name
Disqualifiers
Participants who are receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ixazomib or other agents used in study
Chronic systemic treatment using strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort is not allowed. Patients who are on chronic use of strong CYP3A inducers must come off 14 days before receiving ixazomib treatment. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months; or psychiatric illness/social situations that would limit compliance with study requirements. This includes infections requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment but excludes ongoing antibiotic therapy for opportunistic infection (OI) prophylaxis
Trial design
Treatments tested in this trial
- Ixazomib Citrate
- Quality-of-Life Assessment
- Questionnaire Administration
Treatment groups
Sponsors and collaborators
AIDS Malignancy Consortium
Lead sponsor
National Cancer Institute (NCI)
Collaborator