Health Trials

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Propranolol

    Drug

    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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: PropranololExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate

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.

Time frame
At one year

Secondary outcomes

1

Number of dose-limiting toxicities

To evaluate the number of dose-limiting toxicities. The dose-limiting toxicities will be based on the National Cancer Institute's Common Terminology Criteria for Adverse Events

Time frame
At one year
2

Number of treatment-emergent adverse events

To evaluate the number of treatment-emergent adverse events. The treatment-emergent adverse events will be based on the National Cancer Institute's Common Terminology Criteria for Adverse Events

Time frame
At one year
3

Complete and Partial Response rates in children and adults

Proportion of children and adults with a Complete Response or Partial Response.

Time frame
At one year
4

Time to recurrence among children

Time to recurrence among responders overall in children. Recurrent disease is defined as the appearance of tumor following documentation of a complete remission.

Time frame
At one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AIDS Malignancy Consortium

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: