NCT06445166

Propranolol for the Treatment of Kaposi Sarcoma in Adults

A Multicenter Phase II Study of Propranolol for the Treatment of Kaposi Sarcoma in Adults

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Kaposi Sarcoma

Interventions

Type	Name	Description
DRUG	Propranolol Hydrochloride	Dosing is as follows: * Patients who weigh 40 to 59.9 kg: * 40 mg BID (target) * 20 mg BID (half the target) * Patients who weigh ≥ 60 kg: * 60 mg BID (target) * 30 mg BID (half the target)

Timeline

• Start date: 2025-08-20
• Primary completion: 2028-02-01
• Completion: 2028-08-01
• First posted: 2024-06-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study