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Kaposi SarcomaPhase 2NCT05797662

A Study of Propranolol to Treat Kaposi Sarcoma

A Phase 2 study testing Propranolol in people with Kaposi Sarcoma, run by AIDS Malignancy Consortium at 6 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A clinical study of propranolol for the treatment of Kaposi Sarcoma in children and adults. This study will be an open-label single armed treatment trial that will test the effectiveness and the safety of treating Kaposi Sarcoma with propranolol. Read more about this study

Who is it for?
Any age
Conditions the study is for
Kaposi Sarcoma
What is being tested?
Propranolol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
6 sitesin 5 countries
Study dates
31 Aug 2026to Mar 2029
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Pediatric (< 18 years) and adult (≥ 18 years) participants with biopsy-proven and measurable Kaposi Sarcoma (KS) as defined in the KS Manual of Procedures (MOP).
  • No urgent clinical indication for immediate cytotoxic chemotherapy. Participants who have received cytotoxic chemotherapy > 4 weeks prior to screening are eligible.
  • KS stage:
  • < 18 years:
  • 1A (Mild): disease limited to skin, flat oral mucosal lesions, and/or flesh colored subcutaneous nodules, total <10 lesions.
  • 1B (Moderate): having any of the following features, alone or in combination: a total of 10-19 hyperpigmented skin/oral lesions, nodular oral involvement, conjunctival eye involvement, or exophytic mass.
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  • ≥ 18 years:
  • T0: confined to skin and/or lymph nodes and/or minimal oral lesions.
  • T1: limited to tumor-associated edema of cutaneous lesions without functional impairment or flat oral lesions.
  • Performance Status:
  • < 18 years:
  • Lansky performance status > 70%
  • ≥ 18 years:
  • Easter Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Participants must have adequate organ function, as defined by the following:
  • Bilirubin (direct or total) within normal range, or total bilirubin <3.0 mg/dl for participants with Gilbert syndrome.
  • Calculated creatinine clearance ≥ 30 mL/min for participants ≥ 12 years (see Appendix III); creatinine <1.5 Upper Limit Normal (ULN) for participants < 12 years.
  • Hemoglobin > 9 g/dL;
  • Platelets > 100 × 109/L;
  • ANC > 1000 cells/mm3
  • Human Immunodeficiency Virus (HIV) positive participants must be on antiretroviral therapy (ART) that conforms to local standards of care. Participants will have been on ART for at least 12 weeks. Participants will not be excluded based on CD4 count or HIV viral load.
  • HIV positive participants must not show recent improvement on ART that may confound response evaluation:
  • If on ART 12 to 24 weeks, participants 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 eight weeks.
  • HIV-negative participants must not show evidence of improvement in the three months prior to enrollment.
  • No history of asthma or diabetes mellitus (as it is a risk factor for hypoglycemia).
  • No clinically significant cardiovascular disease other than hypertension, which is permitted.
  • No use of beta-adrenergic antagonists for other indications.
  • Not pregnant or planning to become pregnant. Propranolol is United Stats Food and Drug Administration (US FDA) pregnancy category C. At this time, the study team has determined that the unknown risk to a developing fetus is greater than the potential benefit of treatment.
  • Use of effective contraception for women of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months.
  • Women of child bearing potential (WOCBP) must agree to use adequate contraception (oral contraceptive pills, intrauterine device, Nexplanon, Depo-Provera, or permanent sterilization, etc., or another acceptable method as determined by the investigator) prior to study entry, for the duration of study participation.
  • Not breast feeding.

Who cannot join

  • Participants who do not fulfill the criteria as listed in Section 3.1 above, are ineligible. Additionally, the presence of any of the following conditions will exclude a participant from study enrollment:
  • Children and adolescents with lymph node or visceral disease, woody edema, or ≥ 20 cutaneous lesions.
  • Children and adolescents with heart rate or systolic blood pressure <10th percentile for age.
  • Adults with visceral disease or tumor-associated edema causing functional impairment.
  • Shortness of breath, hemoptysis, or moderate/severe cough not attributable to causes other than KS.
  • Bleeding from the mouth or rectum not attributable to causes other than KS.
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  • Treatment for active and serious infection.
  • Children with severe acute malnutrition based on World Health Organization (WHO) criteria (Mid-upper arm circumference <11.5 cm, weight-for height Z-score <-3 or presence of symmetrical pitting edema).
  • Given the risk of hypotension and hypoglycemia, participants must take the study drug with food. If needed, the study team will pursue additional funding to support providing supplemental food for participants who experience food insecurity.
  • Patients who experienced hypersensitivity to propranolol during initiation phase of treatment or had previous known allergy to propranolol or allergy to other β-blockers.
  • Patients with a history of uncompensated heart failure; severe sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree.
  • Patients with diagnosed obstructive airway disease such as asthma, chronic obstructive pulmonary disease (COPD), or bronchiolitis.
  • History of diabetes mellitus (as it is a risk factor for hypoglycemia)
  • Patients receiving concurrent treatment with an anticancer therapy. Patients must not have received any anticancer therapies within 30 days prior to receiving the first dose of investigational treatment.
  • Patients with concern for Kaposi Sarcoma herpesvirus (KSHV) inflammatory cytokine syndrome.

Trial locations and contacts

6 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Shane McAllister, Md, Phd contact

612-301-2205

smcallis@umn.edu

6 sites in 5 countries

Brazil2 sites, 2 recruiting

  • Instituto Nacional de Câncer José de Alencar

    Rio de Janeiro, 20231-050

    Fabio Leal, MD, PhD, 552132076557, fabio.leal@inca.gov.br

    Not yet recruiting

  • Complexo Hospitalar Universitário Professor Edgard Santos

    Salvador

    Carlos Brites, PhD, 55 (71) 3283-8123, crbrites@gmail.com

    Not yet recruiting

Other trials in Brazil

Argentina1 site, 1 recruiting

  • Fundación Huésped

    Buenos Aires

    Maria Jose Rolon, MD, 541148082627, mjrolon@gmail.com

    Recruiting

Other trials in Argentina

Mexico1 site, 1 recruiting

  • Instituto Nacional de Cancerologia

    Mexico City, 14080

    Patricia Volkow, MD, 5255 51026450, pvolkowf@gmail.com

    Patricia Volkow, MD

    Not yet recruiting

Other trials in Mexico

Uganda1 site, 1 recruiting

  • Uganda Cancer Institute

    Kampala

    Jackson Orem, MD, +256 414540 410, jacksonorem@yahoo.co.uk

    Jackson Orem, MD

    Not yet recruiting

Other trials in Uganda

Zimbabwe1 site, 1 recruiting

  • University of Zimbabwe College of Health Sciences

    Harare

    Margaret Borok, MBChB, FRCP, +263 (242) 791-631, mborok@mweb.co.zw

    Margaret Borok, MBChB (Hons) FRCP(UK)

    Not yet recruiting

Other trials in Zimbabwe

About this study

Official title: A Phase II Study of Propranolol for the Treatment of Kaposi Sarcoma in Children and Adults

A clinical study of propranolol for the treatment of Kaposi Sarcoma in children and adults. This study will be an open-label single armed treatment trial that will test the effectiveness and the safety of treating Kaposi Sarcoma with propranolol.

Read the detailed description

Eligible study participants will receive propanolol twice daily for an initial 12-week period. At the conclusion of 12-weeks, response will be assessed. Participants who achieve a complete or partial response will continue propanolol for an additional 6 weeks or 12 weeks, respectively.

Conditions
Kaposi Sarcoma
Being tested
Propranolol
Keywords
Kaposi Sarcoma, Propranolol
Medical subject headings
Sarcoma, Kaposi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropranololDrug

    Adults: Propanolol 120 mg tablets by mouth twice daily for up to 24 weeks Children: Propanolol 3 mg/kg suspension, divided dose twice daily for up to 24 weeks

Study groups in NCT05797662
Study groupRoleWhat they receive
PropranololExperimentalPropranolol Twice Daily (BID) x 12 weeks Dosage: For ages ≤ 12 years: 3mg/kg/day divided BID; for ages > 12 years, 120 mg BID.
Receives: Drug: Propranolol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    ORR is defined as the proportion of participants with complete response (CR), or partial response (PR) based on AIDS Malignancy Consortium Kaposi Sarcoma (AMC KS) Response Criteria.

    Measured: At one year

Secondary outcomes (7)

  1. Number of dose-limiting toxicities

    To evaluate the number of dose-limiting toxicities. The dose-limiting toxicities will be based on the National Cancer Institute's Common Terminology Criteria for Adverse Events

    Measured: At one year

  2. Number of treatment-emergent adverse events

    To evaluate the number of treatment-emergent adverse events. The treatment-emergent adverse events will be based on the National Cancer Institute's Common Terminology Criteria for Adverse Events

    Measured: At one year

  3. Complete and Partial Response rates in children and adults

    Proportion of children and adults with a Complete Response or Partial Response.

    Measured: At one year

  4. Time to recurrence among children

    Time to recurrence among responders overall in children. Recurrent disease is defined as the appearance of tumor following documentation of a complete remission.

    Measured: At one year

  5. Time to recurrence among adults

    Time to recurrence among responders overall in adults. Recurrent disease is defined as the appearance of tumor following documentation of a complete remission.

    Measured: At one year

  6. Time to progression among children

    Time to progression among responders overall in children. Time to progression is defined as time from initiation of propranolol to documentation of first progression.

    Measured: At one year

  7. Time to progression among adults

    Time to progression among responders overall in adults. Time to progression is defined as time from initiation of propranolol to documentation of first progression.

    Measured: At one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start31 Aug 2026
  3. Primary completionSep 2028 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05797662
Sponsor's protocol ID
AMC-116
Other IDs
UM1CA121947
Status last verified
Oct 2026
First submitted
22 Mar 2023
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Propranolol in people with Kaposi Sarcoma, run by AIDS Malignancy Consortium at 6 sites in 5 countries.

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 32 inclusion and 15 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Brazil, Argentina, Mexico, Uganda, Zimbabwe. 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 Shane McAllister, Md, Phd (612-301-2205, smcallis@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: At one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05797662.

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 5 Oct 2026.

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