Pomalidomide Treatment for Patients with Kaposi Sarcoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04577755

Provider View

This study is testing the effects of the drug pomalidomide on patients with Kaposi sarcoma, a type of cancer. Pomalidomide may help by stopping blood vessel growth, boosting the immune system, and killing cancer cells.

Patient Parameters

Program Overview

This phase II clinical trial is exploring how well the drug pomalidomide works in treating patients with Kaposi sarcoma, a cancer that can affect the skin and other organs. Pomalidomide is believed to help by stopping the growth of blood vessels that feed tumors, boosting the immune system, and directly killing cancer cells. The study aims to see if patients respond to the treatment for at least one year and to evaluate the overall response rate, safety, and changes in the disease.

Description

The main goal of this study is to see how many patients with Kaposi sarcoma respond to pomalidomide treatment for at least one year. The study will also look at how many patients show a complete or partial response to the treatment, both in those with and without HIV. Researchers will assess the safety of pomalidomide and any changes in the disease, especially in patients with internal organ involvement.

The study will also explore how pomalidomide affects the tumor environment, immune cells, and virus levels in the body. Patients will take pomalidomide by mouth once a day for 21 days in a 28-day cycle, for up to 12 cycles. If the disease is stable or improving, treatment may continue for another 12 cycles. Patients will have regular check-ups, including blood tests and possibly tissue biopsies, to monitor their health and the treatment's effects.

After finishing the treatment, patients will have follow-up visits every six months for up to five years to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must understand and agree to sign a consent form.
  • Must have confirmed Kaposi sarcoma with at least five measurable skin lesions or a total lesion area of at least 700 mm².
  • Must have documentation of HIV status:
    • If HIV negative, a recent negative test is required.
    • If HIV positive, proof of HIV diagnosis and treatment is needed.
  • Must be 18 years or older.
  • Must have a good performance status and a life expectancy of more than six months.
  • Must meet specific blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
  • HIV positive patients must be on stable antiretroviral therapy with an undetectable viral load.
  • Must agree to participate in the POMALYST Risk Evaluation and Mitigation Strategy (REMS) program.
  • Must be able to take daily aspirin or an alternative for blood clot prevention.
  • Participants with impaired decision-making capacity must have a legally authorized representative to consent.

Exclusion Criteria

  • Cannot be on other experimental treatments.
  • Cannot have severe internal organ involvement from Kaposi sarcoma needing immediate treatment.
  • Cannot have allergies to pomalidomide or similar drugs.
  • Cannot use certain medications that interact with pomalidomide.
  • Cannot have uncontrolled illnesses or heart conditions.
  • Cannot be pregnant or breastfeeding.
  • Cannot have had recent cancer treatments, except for antiretroviral therapy.
  • Cannot have other serious health conditions that might interfere with the study.
  • Cannot have a history of certain blood disorders or previous use of pomalidomide or similar drugs.

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