Pomalidomide Treatment in Patients With Kaposi Sarcoma

Summary

Participation Requirements

Description

PRIMARY OBJECTIVE: I. To assess the proportion of participants with Kaposi sarcoma (KS) (with or without human immunodeficiency virus [HIV], regardless of previous treatment status) treated with pomalidomide who respond to treatment with a durable response (i.e., response duration of at least one ye...

PRIMARY OBJECTIVE: I. To assess the proportion of participants with Kaposi sarcoma (KS) (with or without human immunodeficiency virus [HIV], regardless of previous treatment status) treated with pomalidomide who respond to treatment with a durable response (i.e., response duration of at least one year). SECONDARY OBJECTIVES: I. To determine progression free survival (PFS) in participants with KS. II. To estimate the overall response rate (ORR) in subgroups of KS in regard to HIV and previous treatment status. III. To assess the safety of pomalidomide therapy. EXPLORATORY OBJECTIVES: I. To assess the effect of pomalidomide treatment on the tumor microenvironment and explore the relationship with clinical response. II. To describe the effects of pomalidomide on CD4 lymphocyte counts and HIV viral load in HIV positive (+) participants. III. To assess the effect of pomalidomide treatment on serum biomarkers and explore the relationship with clinical response. IV. To assess Kaposi's sarcoma-associated herpesvirus (KSHV) viral copy number in plasma and explore whether changes correlate with clinical outcome. OUTLINE: Patients receive pomalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, patients with complete response, partial response, or stable disease may continue pomalidomide for an additional 12 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 5 years.

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