A Study of Propranolol to Treat Kaposi Sarcoma

January 22, 2026 updated by: AIDS Malignancy Consortium

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shane McAllister, Md, Phd
  • Phone Number: 612-301-2205
  • Email: smcallis@umn.edu

Study Locations

  • Argentina
      • Buenos Aires, Argentina
  • Brazil
      • Rio de Janeiro, Brazil, 20231-050
        • Instituto Nacional de Câncer José de Alencar
        • Contact:
      • Salvador, Brazil
        • Complexo Hospitalar Universitário Professor Edgard Santos
        • Contact:
  • Kenya
      • Eldoret, Kenya
        • Moi University School of Medicine
        • Contact:
        • Principal Investigator:
          • Naftali Busakhala, MBChB MMed
  • Malawi
      • Lilongwe, Malawi
        • UNC Project Malawi
        • Contact:
        • Principal Investigator:
          • Lameck Chinula
  • Mexico
      • Mexico City, Mexico, 14080
        • Instituto Nacional de Cancerologia
        • Contact:
        • Principal Investigator:
          • Patricia Volkow, MD
  • South Africa
      • Cape Town, South Africa
        • African Cancer Institute at Stellenbosch
        • Principal Investigator:
          • Hennie Botha
        • Contact:
  • Uganda
      • Kampala, Uganda
        • Uganda Cancer Institute
        • Contact:
        • Principal Investigator:
          • Jackson Orem, MD
  • Zimbabwe
      • Harare, Zimbabwe
        • University of Zimbabwe College of Health Sciences
        • Contact:
          • Margaret Borok, MBChB, FRCP
          • Phone Number: +263 (242) 791-631
          • Email: mborok@mweb.co.zw
        • Principal Investigator:
          • Margaret Borok, MBChB (Hons) FRCP(UK)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propranolol
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: At one year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of dose-limiting toxicities
Time Frame: At one year
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
At one year
Number of treatment-emergent adverse events
Time Frame: At one year
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
At one year
Complete and Partial Response rates in children and adults
Time Frame: At one year
Proportion of children and adults with a Complete Response or Partial Response.
At one year
Time to recurrence among children
Time Frame: At one year
Time to recurrence among responders overall in children. Recurrent disease is defined as the appearance of tumor following documentation of a complete remission.
At one year
Time to recurrence among adults
Time Frame: At one year
Time to recurrence among responders overall in adults. Recurrent disease is defined as the appearance of tumor following documentation of a complete remission.
At one year
Time to progression among children
Time Frame: At one year
Time to progression among responders overall in children. Time to progression is defined as time from initiation of propranolol to documentation of first progression.
At one year
Time to progression among adults
Time Frame: At one year
Time to progression among responders overall in adults. Time to progression is defined as time from initiation of propranolol to documentation of first progression.
At one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIDS Malignancy Consortium

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Shane McAllister, Md, PhD, University of Minnesota Medical School Department of Pediatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC-116
  • UM1CA121947 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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