Propranolol for the Treatment of Kaposi Sarcoma in Adults

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06445166
Phase
PHASE2
Status
Recruiting
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Conditions

  • Kaposi Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Propranolol Hydrochloride — DRUG
    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)

Study Details

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.

Key Dates

Start date
Aug 20, 2025
Status verified
Mar 2026
Primary completion
Feb 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Propranolol
    Begin at 1/2 the target dose for 7 days, followed by a tolerability assessment. Patients intolerant of the half dose will discontinue treatment. Patients who tolerate the 1/2 dose will increase to the full dose for 7 days, after which tolerability will be assessed on day 8. Patients who do not tolerate the full dose will taper and then discontinue treatment. Those who continue will take the target dose for 12 weeks. At week 13 time point, tolerability and response assessment will be performed: * Complete response or partial response: continue at the target dose. * No response (stable disease/disease progression):dose reduction to 1/2 dose for 7 days then discontinue treatment. Patients who stay on propranolol will undergo tolerability assessments as per the protocol. Patients found to be intolerant of propranolol, or patients who have completed 21 weeks of treatment, will undergo dose reduction to the 1/2 dose for 7 days, and then propranolol will be discontinued.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Through completion of treatment (estimated to be 22 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Lee Ratner, M.D., Ph.D.
[email protected]
314-362-8836
Lee Ratner, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Kandice Roberts, M.D. (SUB_INVESTIGATOR)
Feng Gao, M.D., Ph.D. (SUB_INVESTIGATOR)

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By research site
Washington University School of Medicine· St Louis, MO

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