Pomalidomide + Liposomal Doxorubicin for Kaposi Sarcoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byRamya M Ramaswami, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

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 ...

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

All HIV+ patients must be willing to be compliant with HAART

My Kaposi's sarcoma didn't respond well to chemotherapy.

All study participants must agree to be registered into the mandatory POMALYST REMS program, and be willing and able to comply with the requirements of the POMALYST REMS program

+13 more

Exclusion Criteria

You are taking any other experimental drugs.

You have had allergic reactions to certain medications similar to the one being studied.

I have a type of cancer that is not skin cancer, cervical, or anal dysplasia.

+3 more

Participant Groups

The study tests a drug combo for treating KS: IV liposomal doxorubicin on day one of each cycle and daily oral pomalidomide tablets for the first three weeks of each cycle. Treatment continues as long as it's tolerated and effective, with regular monitoring up to five years post-treatment.

4Treatment groups

Experimental Treatment

Group I: 4/Group II; Antitumor Assessment PhaseExperimental Treatment2 Interventions

Pomalidomide and liposomal doxorubicin, given at the highest tolerated dose to patients with KS or KS with concurrent KSHV-associated MCD or KICS requiring systemic therapy

Group II: 3/Group IIExperimental Treatment2 Interventions

Pomalidomide with liposomal doxorubicin given at escalating doses in to patients with advanced KS or KS and concurrent KSHV-associated MCD or KICS requiring systemic therapy

Group III: 2/Group I; Antitumor Assessment PhaseExperimental Treatment2 Interventions

Pomalidomide and liposomal doxorubicin, given at the highest tolerated dose to patients with KS requiring systemic therapy

Group IV: 1/Group IExperimental Treatment2 Interventions

Pomalidomide and liposomal doxorubicin given at escalating doses to patients with KS requiring systemic therapy

Liposomal Doxorubicin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Caelyx for: