A Study of Propranolol to Treat Kaposi Sarcoma
ConditionKaposi Sarcoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAIDS Malignancy Consortium
About this trial
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.
Eligibility criteria
Qualifiers
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.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Propranolol
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
9Argentina
Fundación Huésped Buenos Aires Argentina
Brazil
Instituto Nacional de Câncer José de Alencar20231-050, Rio de Janeiro Brazil
Complexo Hospitalar Universitário Professor Edgard Santos Salvador Brazil
Kenya
Moi University School of Medicine Eldoret Kenya
Sponsors and collaborators
AIDS Malignancy Consortium
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov