Pomalidomide + Liposomal Doxorubicin for Kaposi Sarcoma
Trial Summary
What is the purpose of this trial?
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 ...
Will I have to stop taking my current medications?
The trial requires a 3-week period without treatment (washout period) for most participants, except those with severe, progressive disease. This suggests you may need to stop some current medications, but it's best to discuss your specific situation with the trial team.
What data supports the effectiveness of the drug Pomalidomide + Liposomal Doxorubicin for Kaposi Sarcoma?
Research shows that liposomal doxorubicin (Doxil) is effective in treating Kaposi's sarcoma, especially in patients with HIV, by reducing tumor size and improving symptoms. It is also associated with fewer side effects compared to traditional chemotherapy, making it a safer option for patients.12345
Is the combination of Pomalidomide and Liposomal Doxorubicin safe for humans?
Liposomal Doxorubicin (also known as Doxil or Caelyx) is generally considered safer than conventional doxorubicin, with reduced heart-related side effects and less hair loss. However, it can still cause side effects like myelosuppression (a decrease in bone marrow activity), digestive symptoms, and skin issues such as hand-foot syndrome. Pomalidomide's safety profile is not detailed here, but it is important to discuss potential risks with your healthcare provider.12567
How is the drug Pomalidomide + Liposomal Doxorubicin unique for treating Kaposi Sarcoma?
This drug combination is unique because it uses pegylated liposomal doxorubicin, which is designed to reduce severe side effects like heart damage and low blood cell counts while maintaining high drug concentration in tumor tissues, potentially leading to better outcomes compared to conventional chemotherapy.12389
Research Team
Ramya M Ramaswami, M.D.
Principal Investigator
National Cancer Institute (NCI)
Eligibility Criteria
This trial is for adults with Kaposi sarcoma (KS), including those with HIV. Participants must have confirmed KS, measurable lesions or assessable disease, and normal organ/marrow function. They should not have had certain treatments that would affect lesion assessment and must be willing to follow specific safety programs like POMALYST REMS if taking pomalidomide.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pomalidomide and liposomal doxorubicin in 4-week cycles, with Doxil administered via IV on Day 1 and pomalidomide tablets taken daily for the first 3 weeks of each cycle.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits for up to 5 years.
Treatment Details
Interventions
- Liposomal Doxorubicin
- Pomalidomide
Liposomal Doxorubicin is already approved in European Union, United States, Canada, Japan for the following indications:
- Ovarian cancer
- Breast cancer
- Kaposi's sarcoma
- Multiple myeloma
- Ovarian cancer
- Breast cancer
- Kaposi's sarcoma
- Multiple myeloma
- Ovarian cancer
- Breast cancer
- Kaposi's sarcoma
- Ovarian cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor