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

NCT02659930 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-04-30

No results posted yet for this study

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

...

Conditions

  • Kaposi Sarcoma

Interventions

DRUG

liposomal doxorubicin

liposomal doxorubicin IV day 1 of a 28-day cycle

DRUG

pomalidomide

pomalidomide once a day, days 1-21 of a 28-day cycle, at the dose levels described in dose escalation plan

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Ramya M Ramaswami, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-13
Primary Completion
2028-01-01
Completion
2029-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02659930 on ClinicalTrials.gov