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Could a common heart drug treat kaposi sarcoma?
NCT ID NCT05797662
First seen Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether propranolol, a drug usually used for high blood pressure, can treat Kaposi sarcoma. About 25 children and adults will take propranolol pills for up to 24 weeks. Researchers will measure how many participants see their tumors shrink or disappear, and track any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- propranolol
- What this could lead to
- If it works, this could offer a low-cost, well-tolerated treatment option for Kaposi sarcoma, potentially reducing the need for chemotherapy.
- What could go wrong
- This is a small, early-phase trial with only 25 participants and no comparison group. Propranolol may not shrink tumors effectively, and side effects like low blood pressure or fatigue are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: • 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Complexo Hospitalar Universitário Professor Edgard Santos
Salvador, Brazil
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Fundación Huésped
Buenos Aires, Argentina
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Instituto Nacional de Cancerologia
Mexico City, 14080, Mexico
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Instituto Nacional de Câncer José de Alencar
Rio de Janeiro, 20231-050, Brazil
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Uganda Cancer Institute
Kampala, Uganda
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University of Zimbabwe College of Health Sciences
Harare, Zimbabwe
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Scientists seek tissue samples to unlock HIV-Cancer mysteries
- New drug shows promise in blocking kaposi sarcoma growth
- Can a smaller dose of this cancer drug still work? new trial aims to find out
- New hope for rare cancers: immunotherapy drug targets tumors regardless of origin