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 groupSponsors and collaborators
AIDS Malignancy Consortium
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov