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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 1 Trial of Pomalidomide in Combination With Liposomal Doxorubicin in Patients With Advanced or Refractory Kaposi Sarcoma

Brief 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 sta

Detailed Summary:

Background:

  • Kaposi Sarcoma (KS) is a multicentric angioproliferative tumor that most frequently involves skin, but can also involve lymph nodes, lungs and gastrointestinal tract. It is most common in people with HIV or other forms of immune compromise. Patients with AIDS-associated KS have worse survival than HIV-infected patients without KS.
  • Patients may present with advanced disease KS and/or concurrent KSHV-associated multicentric Castleman disease (MCD) or an IL-6 related KSHV-associated cytokine syndrome (KICS). Patients with the latter conditions have poor outcomes when treated with FDA-approved cytotoxic therapies used for KS, and novel approaches are needed.
  • A Phase I/II Study demonstrated that pomalidomide 5 mg daily on days 1- 21 of a 28 Day Cycle was safe and tolerable in patients with KS with or without HIV. Increased CD4+ and CD8+ T-cell counts and KS regression were observed.
  • Combination of pomalidomide with liposomal doxorubicin may offer a new approach for patients with advanced KS or KS and concurrent KSHV-associated MCD or KICS

Objectives:

  • Evaluate the safety and tolerability of various dose combinations of pomalidomide and liposomal doxorubicin in two groups of patients: Group I) KS requiring systemic therapy; Group II) KS with concurrent KSHV-associated MCD or KICS
  • To assess the pharmacokinetics (PK) of pomalidomide in combination with liposomal doxorubicin; and for patients with HIV in combination with antiretroviral therapy

Eligibility:

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    Sponsor: National Cancer Institute (NCI)

    Current Primary Outcome:

    • safety/tolerability of dose combinations [ Time Frame: 3 months ]
    • pharmacokinetics of combination therapy [ Time Frame: first 3 days of cycle ]


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: January 20, 2016
    Date Started: January 4, 2016
    Date Completion: November 30, 2021
    Last Updated: May 12, 2017
    Last Verified: April 11, 2017