NCT05797662

Brief 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.

Trial Health

70
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
31mo left

Started Sep 2026

Geographic Reach
8 countries

9 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
3.4 years until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

March 22, 2023

Last Update Submit

January 22, 2026

Conditions

Kaposi Sarcoma

Keywords

Kaposi SarcomaPropranolol

Outcome Measures

Primary Outcomes (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.

    At one year

Secondary Outcomes (7)

  • Number of dose-limiting toxicities

    At one year

  • Number of treatment-emergent adverse events

    At one year

  • Complete and Partial Response rates in children and adults

    At one year

  • Time to recurrence among children

    At one year

  • Time to recurrence among adults

    At one year

  • +2 more secondary outcomes

Study Arms (1)

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.

Drug: Propranolol

Interventions

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

Propranolol

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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:
  • A (Mild): disease limited to skin, flat oral mucosal lesions, and/or flesh colored subcutaneous nodules, total \<10 lesions.
  • B (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:
  • +17 more criteria

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Fundación Huésped

Buenos Aires, Argentina

Location

Instituto Nacional de Câncer José de Alencar

Rio de Janeiro, 20231-050, Brazil

Location

Complexo Hospitalar Universitário Professor Edgard Santos

Salvador, Brazil

Location

Moi University School of Medicine

Eldoret, Kenya

Location

UNC Project Malawi

Lilongwe, Malawi

Location

Instituto Nacional de Cancerologia

Mexico City, 14080, Mexico

Location

African Cancer Institute at Stellenbosch

Cape Town, South Africa

Location

Uganda Cancer Institute

Kampala, Uganda

Location

University of Zimbabwe College of Health Sciences

Harare, Zimbabwe

Location

MeSH Terms

Conditions

Sarcoma, Kaposi

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Shane McAllister, Md, PhD

    University of Minnesota Medical School Department of Pediatrics

    STUDY CHAIR

Central Study Contacts

Shane McAllister, Md, Phd

CONTACT

612-301-2205smcallis@umn.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 4, 2023

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

ZI(1)UG(1)MA(1)BR(2)ME(1)ZA(1)AR(1)KE(1)