Actively Recruiting
Propranolol for the Treatment of Kaposi Sarcoma in Adults
Led by Washington University School of Medicine · Updated on 2026-04-06
25
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
T
The Foundation for Barnes-Jewish Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Kaposi sarcoma (KS) lesions are initiated by endothelial cells infected with KS herpesvirus (KSHV), also known as human herpesvirus 8 (HHV-8). Lesion progression is driven by abnormal angiogenesis, chronic inflammation, and uncontrolled cell proliferation. KS remains one of the most commonly diagnosed cancers in many African countries where economic constraints prevent successful treatment in most patients. Treatment outcomes in developed countries are also often unsatisfactory in HIV positive patients despite good virological and immunological responses to antiretroviral therapy. Therefore, identification of new oral, safe treatment options for treatment of KS remains a research priority. Given the known anti-angiogenic properties and based on the treatment response with other benign vascular lesions such as infantile hemangioma, propranolol is a good candidate for the treatment of KS. The hypothesis of this study is that treating patients with Kaposi sarcoma with propranolol will result in an overall response rate (complete response rate plus partial response rate) of at least 45%, and that propranolol will be safe and well tolerated in this patient population.
CONDITIONS
Official Title
Propranolol for the Treatment of Kaposi Sarcoma in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy proven Kaposi Sarcoma measurable with a millimeter ruler
- Two lesions at least 4 mm x 4 mm or one lesion at least 8 mm x 8 mm accessible for 4-mm punch biopsy
- At least 5 additional lesions besides the ones biopsied
- Age 18 years or older
- Weight at least 40 kg
- ECOG performance status 0 to 2
- HIV positive patients must be on stable antiretroviral therapy for at least 12 weeks with specific progression criteria
- HIV negative patients must show no improvement in KS lesions in the 12 weeks before enrollment
- Women of childbearing potential must agree to use adequate contraception during and one month after the study
- Ability to take oral medication
- Ability and willingness to sign informed consent
You will not qualify if you...
- Visceral disease causing functional impairment unless minor and self-limiting
- Need for immediate cytotoxic chemotherapy; prior chemotherapy allowed if more than 4 weeks before screening
- Prior or current malignancy interfering with safety or efficacy assessment
- Current use of beta-adrenergic antagonists; prior use allowed if last dose at least 5 half-lives before Day -7
- Receiving anticancer therapy or investigational agents within 4 weeks prior to propranolol start
- Allergic reactions to propranolol or similar compounds
- History or current diagnosis of asthma, COPD, or bronchiolitis with recent acute episodes
- History of diabetes mellitus as defined by specific glucose criteria
- History of uncompensated heart failure, severe bradycardia, sick sinus syndrome, or advanced heart block
- History of hypotension or orthostasis
- Significant respiratory symptoms not related to KS
- Bleeding from mouth or rectum not related to KS unless minor and self-limiting
- Uncontrolled illnesses including active infection, symptomatic heart failure, unstable angina, or arrhythmia
- Concern for active KSHV inflammatory cytokine syndrome
- Pregnant or breastfeeding women; women must have negative pregnancy test within 21 days
- Untreated or detectable chronic hepatitis B virus infection unless on suppressive therapy
- Untreated or detectable hepatitis C virus infection unless cured or on treatment with undetectable viral load
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
L
Lee Ratner, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here