Propranolol for the Treatment of Kaposi Sarcoma in Adults
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Washington University School of Medicine
You may qualify if…
- ✓ Biopsy proven Kaposi Sarcoma that is measurable with a millimeter ruler. Patients presenting for both front-line therapy and subsequent-line therapy will be considered.
- ✓ Must have two lesions greater than or equal to 4 mm x 4 mm, or one lesion greater than or equal to 8 mm x 8 mm, that are accessible for 4-mm punch biopsy. The patient must have at least 5 more lesions in addition to the lesion(s) being biopsied.
- ✓ At least 18 years of age.
- ✓ Weight ≥40 kg
- ✓ ECOG performance status ≤ 2
- ✓ Meets the appropriate HIV-related criteria:
- ✓ If HIV positive, patient must be on antiretroviral therapy (ART) that conforms to local standards of care for at least 12 weeks. HIV positive patients will not be excluded based on CD4 count or HIV viral load.
- ✓ If on ART 12 to 24 weeks, must show evidence of KS progression requiring further systemic treatment.
You may not qualify if…
- ✕ Visceral disease causing functional impairment. Unless it is a minor, self-limiting (not affecting normal activities) condition.
- ✕ Urgently clinically indicated for immediate cytotoxic chemotherapy. Patients who have received cytotoxic chemotherapy \> 4 weeks prior to screening are eligible.
- ✕ Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
- ✕ Currently taking beta-andrenergic antagonist(s) for other indications. Prior use is allowed if the last dose of the beta-andrenergic antagonist is ≥ 5 half-lives of the agent prior to Day -7.
- ✕ Currently receiving concurrent treatment with an anticancer therapy. Patients must not have received any anticancer therapies within 4 weeks prior to receiving the first dose of propranolol.
- ✕ Currently receiving any other investigational agents.
- ✕ A history of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to propranolol.
- ✕ History of asthma or current diagnosis of obstructive airway disease such as asthma, COPD, or bronchiolitis. Patients with mild or well-controlled obstructive airway disease may be included as long as they have not had an acute episode in the last 3 mos requiring more than 4 days/mo of treatment, change of chronic treatment, or visit to medical personnel for treatment of asthma, COPD, or bronchiolitis.
Where it's recruiting
St Louis
Source: ClinicalTrials.gov · NCT06445166 · last updated 2026-04-06