Propranolol for the Treatment of Kaposi Sarcoma in Adults
ConditionKaposi Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
Kaposi sarcoma (KS) lesions are initiated by endothelial cells infected with KS herpesvirus (KSHV), also known as human herpesvirus 8 (HHV-8). Lesion progression is driven by abnormal angiogenesis, chronic inflammation, and uncontrolled cell proliferation. KS remains one of the most commonly diagnosed cancers in many African countries where economic constraints prevent successful treatment in most patients. Treatment outcomes in developed countries are also often unsatisfactory in HIV positive patients despite good virological and immunological responses to antiretroviral therapy. Therefore, identification of new oral, safe treatment options for treatment of KS remains a research priority. Given the known anti-angiogenic properties and based on the treatment response with other benign vascular lesions such as infantile hemangioma, propranolol is a good candidate for the treatment of KS. The hypothesis of this study is that treating patients with Kaposi sarcoma with propranolol will result in an overall response rate (complete response rate plus partial response rate) of at least 45%, and that propranolol will be safe and well tolerated in this patient population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Biopsy proven Kaposi Sarcoma that is measurable with a millimeter ruler. Patients presenting for both front-line therapy and subsequent-line therapy will be considered.
Must have two lesions greater than or equal to 4 mm x 4 mm, or one lesion greater than or equal to 8 mm x 8 mm, that are accessible for 4-mm punch biopsy. The patient must have at least 5 more lesions in addition to the lesion(s) being biopsied.
At least 18 years of age.
Weight ≥40 kg
Disqualifiers
Visceral disease causing functional impairment. Unless it is a minor, self-limiting (not affecting normal activities) condition.
Urgently clinically indicated for immediate cytotoxic chemotherapy. Patients who have received cytotoxic chemotherapy > 4 weeks prior to screening are eligible.
Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
Currently taking beta-andrenergic antagonist(s) for other indications. Prior use is allowed if the last dose of the beta-andrenergic antagonist is ≥ 5 half-lives of the agent prior to Day -7.
Trial design
Design model
Single group
Treatments tested in this trial
Propranolol Hydrochloride
DrugDosing is as follows: * Patients who weigh 40 to 59.9 kg: * 40 mg BID (target) * 20 mg BID (half the target) * Patients who weigh ≥ 60 kg: * 60 mg BID (target) * 30 mg BID (half the target)
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: PropranololExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
ORR is defined as the proportion of participants with complete response (CR) or partial response (PR) based on AMC KS Response Criteria.
Time frame
Through completion of treatment (estimated to be 22 weeks)Secondary outcomes
1
Incidence of intolerable toxicities and treatment-emergent adverse events (TEAEs) based on CTCAE v 5.0.
Time frame
From start of treatment through 30 days after completion of treatment (estimated to be 26 weeks)2
Time to recurrence or progression among responders overall.
Time frame
Through completion of follow-up (estimated to be 6 months and 22 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
The Foundation for Barnes-Jewish Hospital
Collaborator
Source ClinicalTrials.gov