Phase of Study:

Phase II

Participating Institutions:

This protocol will be open to all AMC international member sites in sub-Saharan Africa. Participating institutions will also be required to complete Celgene’s pregnancy prevention counseling training before activating this trial.

Accrual Target:

30 participants

Population:

Participants with KS and HIV infection.

Regimen:

Each cycle of treatment includes administration of 21 doses of pomalidomide during a 4-week period, administered on Days 1-21 of a 28-day cycle.

Eligible participants will begin pomalidomide therapy at Dose Level 1, 4 mg/day on Days 1-21 of each 28-day cycle.

Dose level -1, 3 mg/day on Days 1-21 of each 28-day cycle, is provided for participants entered on Dose Level 1 who require dose reduction.

Safety and the need for dose reduction will be continuously monitored by the protocol team.

Antitumor effects will be assessed immediately prior to the start of each 28-day treatment cycle in all participants and every 12 weeks after completion of pomalidomide therapy in participants showing complete or partial response.

Duration:

The maximum duration of treatment is 12, 4-week cycles.

Primary Objective:

To determine if pomalidomide monotherapy induces a minimal level of antitumor efficacy to justify its further development for HIV-associated KS in sub-Saharan Africa and is safe and tolerable.

Secondary Objectives:

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.

Exploratory Objectives:

1. To assess the effect of pomalidomide treatment on serum cytokine levels.
2. To evaluate if changes in serum cytokine levels correlate with clinical response.