Propranolol for Kaposi Sarcoma

Recruiting at 3 trial locations

Overseen By Lee Ratner, M.D., Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must be taking: Antiretroviral therapy

Must not be taking: Beta blockers, Anticancer therapies

Disqualifiers: Asthma, Diabetes, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 22 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether propranolol, a medication typically used for heart issues, can help treat Kaposi sarcoma, a cancer that causes skin lesions. The researchers aim to determine if propranolol can reduce lesion size and ensure its safety for patients with Kaposi sarcoma, particularly those with HIV. Suitable candidates have Kaposi sarcoma with at least five visible lesions, have been on HIV medication for at least 12 weeks if HIV positive, and can take a pill. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial requires that you stop taking any beta-blockers (a type of medication often used for heart conditions) and any anticancer therapies at least 4 weeks before starting propranolol. If you are on antiretroviral therapy for HIV, you must continue it as per local standards.

Is there any evidence suggesting that propranolol is likely to be safe for humans?

Research has shown that propranolol is generally safe for treating Kaposi sarcoma (KS), particularly in patients with uncomplicated classic KS. One study found that older patients with various health issues tolerated propranolol well. Another study discovered that propranolol can slow the growth of cells affected by the virus linked to KS.

Although this trial is in its early stages, propranolol is already approved for other uses, such as treating high blood pressure, so its safety is well-researched in general, though not specifically for KS. Participants in this trial will have their safety closely monitored to ensure the treatment is well tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Kaposi sarcoma?

Most treatments for Kaposi Sarcoma, like chemotherapy and antiretroviral therapy, mainly aim to control the disease by attacking cancer cells or boosting the immune system. But propranolol works differently, targeting the blood vessels that feed the tumor, essentially starving it. Researchers are excited about propranolol because it is a beta-blocker, traditionally used for heart conditions, and it has a unique mechanism that could provide an alternative treatment pathway, potentially with fewer side effects. This approach could offer a promising option for patients who may not respond well to existing therapies.

What evidence suggests that propranolol might be an effective treatment for Kaposi sarcoma?

Research has shown that propranolol, a beta-blocker, may help treat Kaposi sarcoma (KS). In this trial, participants will receive propranolol to assess its effectiveness for KS. One study found that propranolol effectively treated patients with a straightforward form of KS. It reduces the growth of abnormal blood vessels, which is crucial in KS. This treatment has also succeeded in similar conditions, such as infantile hemangioma, a type of non-cancerous tumor. These findings suggest it could help shrink KS lesions and improve patient health. ^{1 2 4 5 6}

Who Is on the Research Team?

Lee Ratner, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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 can swallow pills.

My Kaposi's sarcoma has worsened on ART after 12-24 weeks, needing more treatment.

If HIV negative, must not show evidence of improvement in the 12 weeks prior to enrollment.

Exclusion Criteria

I have asthma or another obstructive airway disease.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants begin at 1/2 the target dose for 7 days, followed by a tolerability assessment. If tolerated, they continue with the full/target dose for 7 days, then the target dose for 12 weeks. Depending on response, treatment may continue for an additional 8 weeks.

22 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Propranolol

Trial Overview 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.

How Is the Trial Designed?

Group I: Propranolol Experimental Treatment 1 Intervention

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.

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

Approved in United States as Inderal for:

• High blood pressure
• Angina pectoris
• Heart rhythm disorders
• Migraine prophylaxis
• Essential tremor
• Performance anxiety

Approved in European Union as Propranolol for:

• Hypertension
• Angina pectoris
• Arrhythmias
• Migraine prophylaxis
• Essential tremor
• Anxiety

Approved in Canada as Propranolol for:

• Hypertension
• Angina pectoris
• Arrhythmias
• Migraine prophylaxis
• Essential tremor
• Anxiety

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

The Foundation for Barnes-Jewish Hospital

Collaborator

Trials

43

Recruited

6,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11928098/

A Promising Therapeutic Avenue for Classic Kaposi Sarcoma A recent study demonstrated that topical propranolol 2% cream was more effective than topical timolol gel 0.5% in the treatment of patients with CKS [11]. On ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06445166

Propranolol for the Treatment of Kaposi Sarcoma in Adults The hypothesis of this study is that treating patients with Kaposi sarcoma with propranolol will result in an overall response rate (complete response rate ...

3. dpcj.org dpcj.org/index.php/dpc/article/view/4737

A Promising Therapeutic Avenue for Classic Kaposi Sarcoma Conclusions: Oral propranolol is a safe and good option for treatment of patients with non-complicated classic Kaposi sarcoma, especially ...

4. cancer.gov cancer.gov/clinicaltrials/NCI-2024-07924

Propranolol for the Treatment of Adult Patients with Kaposi ... This phase II trial tests how well propranolol works in treating adult patients with Kaposi sarcoma. Propranolol is a drug that is classified as a beta-blocker.

5. sigma.larvol.com sigma.larvol.com/ott.php?e1=5068&e2=&sourcepg=TZ&sr=now&er=1+month&ipwnd=on&rlink=,sourcepg=TZ,itype=0,1&rflag=1&page=2

Online Trial Tracker NCT05797662: A Study of Propranolol to Treat Kaposi Sarcoma. Not yet recruiting. 2. 25. RoW. Propranolol. AIDS Malignancy Consortium, National Cancer Institute ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4621132/

Propranolol Decreases Proliferation of Endothelial Cells ... Propranolol Decreases Proliferation of Endothelial Cells Transformed by Kaposi's Sarcoma-Associated Herpesvirus and Induces Lytic Viral Gene Expression.