Study on Ixazomib for Treating Kaposi Sarcoma

Sponsor: AIDS Malignancy Consortium

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04305691

Provider View

This clinical trial is testing how well the drug ixazomib works in treating Kaposi sarcoma, a type of cancer. The study aims to see if ixazomib can stop tumor growth by blocking certain enzymes needed for cell growth.

Patient Parameters

Program Overview

This phase II study is investigating the effectiveness of ixazomib in treating patients with Kaposi sarcoma, a cancer that forms in the skin, lymph nodes, or other organs. Ixazomib may help stop the growth of cancer cells by blocking enzymes they need to grow. The study will also look at the safety of ixazomib and its effects on the virus associated with Kaposi sarcoma, as well as changes in quality of life for participants.

Description

The main goal of this study is to see how well ixazomib works in treating Kaposi sarcoma. Researchers will also check how safe the drug is and how it affects the virus linked to Kaposi sarcoma. For participants with HIV, the study will monitor changes in their CD4 counts and HIV viral load. Additionally, the study will explore how ixazomib affects participants' quality of life.

Participants will take ixazomib by mouth on days 1, 8, and 15 of each 28-day cycle. Treatment can continue for up to 12 cycles unless the disease worsens or side effects become too severe. If participants show a complete or partial response, they may continue treatment for another 12 cycles under the same conditions. After finishing the treatment, participants will have follow-up visits for 4 weeks and then periodically for up to 2 years.

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, with specific requirements for both HIV-positive and HIV-negative participants.
  • Must have a performance status score of 2 or less, indicating they are able to carry out light work.
  • Must have a life expectancy of more than 3 months.
  • Must meet specific blood count and organ function criteria.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for 90 days after the last dose.
  • HIV-positive participants must have been on stable antiretroviral therapy with a good response for at least 12 weeks.
  • Must not have shown recent improvement in Kaposi sarcoma on antiretroviral therapy alone that could affect the study results.
  • Participants with residual active Kaposi sarcoma lesions after recent treatment are eligible if the disease requires further treatment and at least 4 weeks have passed since the last therapy.

Exclusion Criteria

  • Cannot be taking other investigational drugs.
  • Cannot have allergies to ixazomib or similar drugs.
  • Cannot be on certain medications that affect how ixazomib works.
  • Cannot have uncontrolled illnesses or infections.
  • Cannot have another cancer that could interfere with the study.
  • Cannot be pregnant or breastfeeding.
  • Cannot have had recent chemotherapy or radiation therapy.
  • Cannot have unresolved side effects from previous cancer treatments.
  • Cannot have active hepatitis B or C infections.
  • Cannot have gastrointestinal issues that affect drug absorption.
  • Cannot have severe nerve damage.
  • Cannot have had major surgery recently.
  • Cannot have symptomatic visceral Kaposi sarcoma.
  • Cannot have been treated with a proteasome inhibitor for Kaposi sarcoma in the last 2 years or with ixazomib at any time.

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