Trial Title:
A Study of Propranolol to Treat Kaposi Sarcoma
NCT ID:
NCT05797662
Condition:
Kaposi Sarcoma
Conditions: Official terms:
Sarcoma, Kaposi
Sarcoma
Propranolol
Conditions: Keywords:
Kaposi Sarcoma
Propranolol
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Propranolol
Description:
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
Arm group label:
Propranolol
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fundación Huésped
Address:
City:
Buenos Aires
Country:
Argentina
Contact:
Last name:
Pedro Cahn, PhD
Phone:
54 (11) 4981-7777
Email:
pedro.cahn@huesped.org.ar
Facility:
Name:
Instituto Nacional de Câncer José de Alencar
Address:
City:
Rio De Janeiro
Zip:
20231-050
Country:
Brazil
Contact:
Last name:
Fabio Leal, MD, PhD
Phone:
552132076557
Email:
fabio.leal@inca.gov.br
Facility:
Name:
Complexo Hospitalar Universitário Professor Edgard Santos
Address:
City:
Salvador
Country:
Brazil
Contact:
Last name:
Carlos Brites, PhD
Phone:
55 (71) 3283-8123
Email:
crbrites@gmail.com
Facility:
Name:
Moi University School of Medicine
Address:
City:
Eldoret
Country:
Kenya
Contact:
Last name:
Naftali Busakhala
Phone:
254-722-496-933
Email:
nbusakhala@yahoo.com
Investigator:
Last name:
Naftali Busakhala, MBChB MMed
Email:
Principal Investigator
Facility:
Name:
UNC Project Malawi
Address:
City:
Lilongwe
Country:
Malawi
Contact:
Last name:
Lameck Chinula
Phone:
265 88 248 3220
Email:
lchinula@unclilongwe.org
Investigator:
Last name:
Lameck Chinula
Email:
Principal Investigator
Facility:
Name:
Instituto Nacional de Cancerologia
Address:
City:
Ciudad de Mexico
Zip:
14080
Country:
Mexico
Contact:
Last name:
Patricia Volkow, MD
Phone:
5255 51026450
Email:
pvolkowf@gmail.com
Investigator:
Last name:
Patricia Volkow, MD
Email:
Principal Investigator
Facility:
Name:
African Cancer Institute at Stellenbosch
Address:
City:
Cape Town
Country:
South Africa
Contact:
Last name:
Hennie Botha, MMed PhD
Phone:
+27 (21) 938-9209
Email:
mhbotha@sun.ac.za
Investigator:
Last name:
Hennie Botha
Email:
Principal Investigator
Facility:
Name:
Uganda Cancer Institute
Address:
City:
Kampala
Country:
Uganda
Contact:
Last name:
Jackson Orem, MD
Phone:
+256 414540 410
Email:
jacksonorem@yahoo.co.uk
Investigator:
Last name:
Jackson Orem, MD
Email:
Principal Investigator
Facility:
Name:
University of Zimbabwe College of Health Sciences
Address:
City:
Harare
Country:
Zimbabwe
Contact:
Last name:
Margaret Borok, MBChB, FRCP
Phone:
+263 (242) 791-631
Email:
mborok@mweb.co.zw
Investigator:
Last name:
Margaret Borok, MBChB (Hons) FRCP(UK)
Email:
Principal Investigator
Start date:
July 1, 2025
Completion date:
August 1, 2029
Lead sponsor:
Agency:
AIDS Malignancy Consortium
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
AIDS Malignancy Consortium
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05797662
