A Study of Propranolol to Treat Kaposi Sarcoma

Starting soon · Phase 2

Conditions studied: Kaposi Sarcoma

In brief

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.

Key facts

Study ID

NCT05797662

Run by

AIDS Malignancy Consortium

People needed

25

Starts

2026-09-01

Expected to finish

2029-04-01

Last updated by the study team

2026-01-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• ≥ 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Fundación Huésped — Buenos Aires, Argentina
• Instituto Nacional de Câncer José de Alencar — Rio de Janeiro, Brazil
• Complexo Hospitalar Universitário Professor Edgard Santos — Salvador, Brazil
• Moi University School of Medicine — Eldoret, Kenya
• UNC Project Malawi — Lilongwe, Malawi
• Instituto Nacional de Cancerologia — Mexico City, Mexico
• African Cancer Institute at Stellenbosch — Cape Town, South Africa
• Uganda Cancer Institute — Kampala, Uganda
• University of Zimbabwe College of Health Sciences — Harare, Zimbabwe

Full record on ClinicalTrials.gov

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