Pomalidomide in Combination With Liposomal Doxorubicin in People With Advanced or Refractory Kaposi Sarcoma
Status:
Recruiting
Trial end date:
2026-11-30
Target enrollment:
Participant gender:
Summary
Background:
Kaposi sarcoma (KS) is a cancer most often seen in people with HIV. It causes lesions. These
are usually on the skin but sometimes in the lymph nodes, lungs, and gastrointestinal tract.
Researchers think a combination of drugs may help treat KS.
Objective:
To test a combination of the anti-cancer drugs pomalidomide (CC-4047) and liposomal
doxorubicin (Doxil) in people with KS.
Eligibility:
People ages 18 and over with KS
Design:
Participants will be screened with:
Medical history
Questionnaires
Physical exam
Blood, urine, and heart tests
Chest X-ray
Biopsy: A small sample of tissue is taken from a KS lesion.
Possible CT scan
Possible exam of lungs or gastrointestinal tract with an endoscope: A flexible instrument
examines
inside the organ.
Participants will take the drugs in 4-week cycles. They will take Doxil through an IV on Day
1 of each cycle. They will take CC-4047 tablets by mouth each day for the first 3 weeks of
each cycle.
Participants will have many visits:
Before starting treatment
To start each cycle
Day 15 of first 2 cycles
Visits include repeats of screening tests and:
Multiple blood draws
Photographs of lesions
Participants will keep a drug diary.
Participants will take aspirin or other drugs to prevent blood clots.
Participants with HIV will have combination antiretroviral therapy.
Some participants will have a PET scan.
Participants will continue treatment as long as they tolerate it and their KS improves. After
treatment, they will have several follow-up visits for up to 5 years
...