Trial of Ixazomib for Kaposi Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAIDS Malignancy Consortium
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Ixazomib Citrate
DrugGiven PO
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Treatment groups
41 Participants
are divided into 1 treatment groupGroup A: Treatment (ixazomib)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Overall response rate
The binomial proportion and its 90% one-sided confidence interval will be used to estimate the overall response rate. Response and progression will be evaluated in this study using the acquired Immunodeficiency syndrome (AIDS) Clinical Trials Groups (ACTG) response criteria for Kaposi sarcoma, as outlined in the AIDS Malignancy Consortium (AMC) Kaposi sarcoma Response Evaluation Manual of Procedures (MOP).
Time frame
Up to 4 weeks post treatmentSecondary outcomes
1
Incidence of adverse events
Frequencies of toxicities will be presented by severity at the event and person level; 95% confidence intervals will be computed for the proportion of participants experiencing grade 3 and higher toxicities. The incidence of toxicity-related dose reductions and treatment discontinuations will be summarized.
Time frame
Up to 4 weeks post treatment2
Change in Kaposi-sarcoma associated herpes virus (KSHV) viral load (VL)
KSHV lytic gene expression over time will be summarized; changes will be graphed and explored using paired t-tests or Wilcoxon signed rank tests. KSHV levels will be correlated with tumor response by computing descriptive statistics and making exploratory comparisons according to response, as well as examining Spearman's rank correlations between tumor size KSHV levels.
Time frame
Baseline up to 4 weeks post treatment3
Change in CD4 counts
Immune status over time will be summarized; changes in immune status will be graphed and explored using paired t-tests or Wilcoxon signed rank tests.
Time frame
Baseline up to 4 weeks post treatment4
Change in human immunodeficiency virus (HIV) VL
HIV viral load over time will be summarized; changes in HIV VL will be graphed and explored using paired t-tests or Wilcoxon signed rank tests. HIV levels will be correlated with tumor response by computing descriptive statistics and making exploratory comparisons according to response, as well as examining Spearman's rank correlations between tumor size and HIV levels.
Time frame
Baseline up to 4 weeks post treatmentOther outcomes
1
Change in quality of life
General estimating equations will be used to evaluate changes in the functional assessment of HIV Infection (FAHI) + Kaposi sarcoma (KS) (FAHI+KS) questionnaire measures over time, accounting for clustering of responses within participants. There are three supplemental statements regarding participant perception of KS-specific symptoms: pain, swelling, and physical appearance. Agreement with each of these statements is graded using a Likert scale from 0 to 4. Responses to these statements may be dichotomized to reflect positive or negative impact of these symptoms.
Time frame
Baseline up to 4 weeks post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
AIDS Malignancy Consortium
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov