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Beta-blocker

Propranolol for Kaposi Sarcoma

Phase 2

Waitlist Available

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

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Weight >40 kg

Must have two lesions greater or equal to 4 x 4 mm that are accessible for 3-mm punch biopsy.

Must not have

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.

Bleeding from the mouth or rectum not attributable to causes other than KS.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of treatment (estimated to be 25 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if propranolol, a drug known for its ability to inhibit blood vessel growth, can be a safe and effective treatment for Kaposi sarcoma, a type of

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, Propranolol generally can cause dizziness, tiredness, and cold hands/feet. More serious but rare side effects include shortness of breath and mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh more than 40 kg.

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

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

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I am 18 years old or older.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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

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I do not have any uncontrolled illnesses or heart problems.

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My internal organ cancer is affecting how my body works.

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I have a history of diabetes.

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I have a history of serious heart conditions.

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

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

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I have asthma or another obstructive airway disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of treatment (estimated to be 25 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of treatment (estimated to be 25 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of treatment (estimated to be 25 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Propranolol Hydrochloride

2021

Completed Phase 3

~130

0 / 17Eligibility criteria met