NCT03601806

Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection

A Phase II Multicenter Study of Pomalidomide Monotherapy in HIV-Positive Individuals With Kaposi Sarcoma (KS) in Sub-Saharan Africa (SSA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: AIDS Malignancy Consortium · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II clinical trial studies the side effects of pomalidomide and how well it works in treating patients with Kaposi sarcoma and human immunodeficiency virus (HIV) infection. Biological therapies, such as pomalidomide, may stimulate the immune system in different ways and stop tumor cells from growing and it may also block the growth of new blood vessels necessary for tumor growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine if pomalidomide monotherapy induces a minimal level of antitumor efficacy to justify its further development for HIV-associated Kaposi sarcoma (KS) in sub-Saharan Africa and is safe and tolerable. SECONDARY OBJECTIVES: I. To evaluate the effects of pomalidomide monotherapy on standard measures of HIV control, i.e., CD4 counts and HIV viral loads, in this participant population. TERTIARY OBJECTIVES: I. To assess the effect of pomalidomide treatment on serum cytokine levels. II. To evaluate if changes in serum cytokine levels correlate with clinical response. OUTLINE: Patients receive pomalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks for 48 weeks.

Conditions

• Human Immunodeficiency Virus 1 Positive
• Skin Kaposi Sarcoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Pomalidomide	Given PO

Timeline

• Start date: 2021-04-26
• Primary completion: 2024-11-29
• Completion: 2025-04-10
• First posted: 2018-07-26
• Last updated: 2026-04-13
• Results posted: 2026-02-02

Locations

3 sites across 3 countries: Kenya, Malawi, Uganda

Regulatory

• FDA-regulated drug study