NCT05797662
Not yet recruiting
Phase 2
A Phase II Study of Propranolol for the Treatment of Kaposi Sarcoma in Children and Adults
AIDS Malignancy Consortium9 sites in 8 countries25 target enrollmentStarted: September 1, 2026Last updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- AIDS Malignancy Consortium
- Enrollment
- 25
- Locations
- 9
- Primary Endpoint
- Objective Response Rate
Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
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.
Arms & Interventions
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.
Intervention: Propranolol (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Number of dose-limiting toxicities(At one year)
- Time to progression among children(At one year)
- Time to progression among adults(At one year)
Investigators
Study Sites (9)
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