Active — Not RecruitingPhase 1

Pomalidomide in Combination With Liposomal Doxorubicin in People With Advanced or Refractory Kaposi Sarcoma

United States62 participantsStarted 2016-01-13

Plain-language 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 ...

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

-Because no dosing or adverse event data are currently available on the use of pomalidomide in combination with liposomal doxorubicin in patients \<18 years of age, children are excluded from this study, but may be eligible for future pediatric trials.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

safety/tolerability of dose combinations

Timeframe: 3 months

pharmacokinetics of combination therapy

Timeframe: first 3 days of cycle

Trial details

NCT IDNCT02659930

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2028-01-01

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