Propranolol for Kaposi Sarcoma

Palo Alto (17 mi)

Overseen byLee Ratner, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Prior Safety Data

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with Kaposi Sarcoma, a cancer caused by the KS herpesvirus. It's looking for participants who need new treatment options, including those in countries with limited access to current treatments or HIV positive patients not responding well despite antiretroviral therapy.

Inclusion Criteria

I weigh more than 40 kg.

I have two or more lesions big enough and accessible for a biopsy.

I have Kaposi Sarcoma that can be measured and I'm seeking treatment.

I am 18 years old or older.

I can take care of myself but might not be able to do heavy physical work.

My Kaposi's sarcoma is in the early stages, affecting only my skin, lymph nodes, or causing minimal oral lesions.

Exclusion Criteria

I am not on cancer treatment and haven't been for the last 4 weeks.

I have bleeding from the mouth or rectum not caused by Kaposi's sarcoma.

I have chronic hepatitis B but it's under control with medication.

I have hepatitis C that is either not cured or still detectable.

I do not have any uncontrolled illnesses or heart problems.

My internal organ cancer is affecting how my body works.

I have a history of diabetes.

I have a history of serious heart conditions.

I have a history of low blood pressure or dizziness when standing up.

My breathing issues or cough are due to Kaposi's sarcoma.

I have asthma or another obstructive airway disease.

Treatment Details

The study tests Propranolol Hydrochloride, known for blocking blood vessel growth and inflammation. The goal is to see if it can treat Kaposi Sarcoma effectively. Researchers hope at least 45% of patients will show major improvement.

1Treatment groups

Experimental Treatment

Group I: PropranololExperimental Treatment1 Intervention

Begin at 1/2 the target dose for 2 days (4 doses), followed by a tolerability assessment. Patients who tolerate the 1/2 dose will begin the target dose on Day 3 for 2 days (4 doses), after which tolerability will be assessed. Patients who do not tolerate the target dose will decrease to a 1/2 dose for 2 days and then discontinue treatment; these patients will be withdrawn from the study and replaced. Those who continue will take the target dose for 12 weeks. At 12-week time point, one of the following paths will be taken: * Complete response: continue taking propranolol at the target dose for another 6 weeks, followed by a reduced dose (1/2 the target) for 7 days, then discontinue treatment * Partial response: continue taking propranolol at the target dose for another 12 weeks, followed by a reduced dose (1/2 the target) for 7 days, then discontinue treatment * No response (stable disease/disease progression):reduced dose (1/2 the target) for 7 days, then discontinue treatment

Propranolol is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Inderal for: