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.
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
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.
6 sites in 5 countries
Brazil2 sites, 2 recruiting
- Not yet 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
Argentina1 site, 1 recruiting
- Recruiting
Fundación Huésped
Buenos Aires
Maria Jose Rolon, MD, 541148082627, mjrolon@gmail.com
Mexico1 site, 1 recruiting
- Not yet recruiting
Instituto Nacional de Cancerologia
Mexico City, 14080
Patricia Volkow, MD, 5255 51026450, pvolkowf@gmail.com
Patricia Volkow, MD
Uganda1 site, 1 recruiting
- Not yet recruiting
Uganda Cancer Institute
Kampala
Jackson Orem, MD, +256 414540 410, jacksonorem@yahoo.co.uk
Jackson Orem, MD
Zimbabwe1 site, 1 recruiting
- Not yet 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)
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 group | Role | What they receive |
|---|---|---|
| Propranolol | Experimental | Propranolol 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.
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)
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
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
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
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
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
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
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.
- First posted4 Apr 2023
- Study start31 Aug 2026
- Primary completionSep 2028 (estimated)
- Study completionMar 2029 (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.
- 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
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shane McAllister, Md, PhD, Study chair, University of Minnesota Medical School Department of Pediatrics
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