Kaposi SarcomaPhase 2NCT06445166
Propranolol for the Treatment of Kaposi Sarcoma in Adults
A Phase 2 study testing Propranolol Hydrochloride in people with Kaposi Sarcoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kaposi Sarcoma
- What is being tested?
- Propranolol Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2025to 1 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
- If on ART for > 24 weeks, must show no evidence of regression in the last 8 weeks.
- If HIV negative, must not show evidence of improvement in the 12 weeks prior to enrollment.
- Propranolol is US FDA pregnancy category C. For this reason, women of childbearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for one month after completion of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, s/e must inform her treating physician immediately.
- Able to take an oral pill.
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Who cannot join
- 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.
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- 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.
- History of diabetes mellitus, as defined by any of the following: A random blood glucose value of at least 200 mg/dL in the presence of hyperglycemia symptoms (weight loss, blurry vision, thirst, polyuria), fasting plasma glucose value of at least 126 mg/dL, A1c value of at least 7.0%, or two hour plasma glucose value of at least 200 mg/dL during a 75 g oral glucose tolerance test.
- History of uncompensated heart failure, severe sinus bradycardia (heart rate persistently <50 beats per minute), sick sinus syndrome, or heart block greater than first degree. Patients with isolated bradycardia may be included as long as the heart rate is at least 51 beats per minute and is asymptomatic.
- History of hypotension (systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg) or orthostasis (>20 mmHg fall in systolic pressure or >10 mmHg fall in diastolic pressure with standing). (Isolated instances of hypotension may not be exclusionary after discussion with PI.)
- Shortness of breath, hemoptysis, or moderate/severe cough not attributable to causes other than KS. Patients may be included if they have a minor, self-limiting condition and their O2 sat is persistently greater than 90% and there is no hemoptysis or cough severe enough to limit normal activities.
- Bleeding from the mouth or rectum not attributable to causes other than KS. Unless it is a minor, self-limiting condition, such as blood tinged toilet paper.
- Uncontrolled intercurrent illness including, but not limited to: ongoing clinically significant active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Concern for KSHV inflammatory cytokine syndrome. Patients with history of prior KSHV inflammatory cytokine syndrome may be included.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 21 days of study entry.
- Evidence of untreated chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with active HBV infection can be enrolled as long as they are receiving HBV treatment. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
- History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Lee Ratner, M.D., Ph.D., 314-362-8836, lratner@wustl.edu
Lee Ratner, M.D., Ph.D.
About this study
Official title: A Multicenter Phase II Study of Propranolol for the Treatment of Kaposi Sarcoma in Adults
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.
- Conditions
- Kaposi Sarcoma
- Being tested
- Propranolol Hydrochloride
- Keywords
- Propranolol, Kaposi, Sarcoma, Phase II, HIV
- Medical subject headings
- Sarcoma, Kaposi, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol HydrochlorideDrug
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 group | Role | What they receive |
|---|---|---|
| Propranolol | Experimental | 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. Receives: Drug: Propranolol Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is defined as the proportion of participants with complete response (CR) or partial response (PR) based on AMC KS Response Criteria.
Measured: Through completion of treatment (estimated to be 22 weeks)
Secondary outcomes (2)
Incidence of intolerable toxicities and treatment-emergent adverse events (TEAEs) based on CTCAE v 5.0.
Measured: From start of treatment through 30 days after completion of treatment (estimated to be 26 weeks)
Time to recurrence or progression among responders overall.
Measured: Through completion of follow-up (estimated to be 6 months and 22 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start20 Aug 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kaposi SarcomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Lee Ratner, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445166
- Sponsor's protocol ID
- 202408004
- Status last verified
- Mar 2026
- First submitted
- 31 May 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data shared will consist of all of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Study of Propranolol for the Treatment of Kaposi Sarcoma in Adults
- ClinicalTrials.gov ID
- NCT06445166
- Acronym / sponsor ID
- 202408004
- Conditions
- Kaposi Sarcoma
- Keywords
- Propranolol, Kaposi, Sarcoma, Phase II, HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Experimental | Drug: Propranolol HydrochlorideBegin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol HydrochlorideDosing 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) | Drug | Propranolol |
Primary outcome
Objective response rate (ORR)
Time frame: Through completion of treatment (estimated to be 22 weeks)
ORR is defined as the proportion of participants with complete response (CR) or partial response (PR) based on AMC KS Response Criteria.
2 secondary outcomes
Incidence of intolerable toxicities and treatment-emergent adverse events (TEAEs) based on CTCAE v 5.0.
Time frame: From start of treatment through 30 days after completion of treatment (estimated to be 26 weeks)
Time to recurrence or progression among responders overall.
Time frame: Through completion of follow-up (estimated to be 6 months and 22 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data shared will consist of all of the individual participant data collected during the trial, after deidentification.
Related trials for Kaposi Sarcoma
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Trial of Ixazomib for Kaposi Sarcoma
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Pomalidomide in Combination With Liposomal Doxorubicin in People With Advanced or Refractory Kaposi Sarcoma
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Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lee Ratner, M.D., Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol Hydrochloride in people with Kaposi Sarcoma, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lee Ratner, M.D., Ph.D. (314-362-8836, lratner@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Through completion of treatment (estimated to be 22 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.