Study on Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin for Mycosis Fungoides

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05357794

Provider View

This clinical trial is testing a combination of a special type of radiation therapy and a drug called brentuximab vedotin to see if it can help control mycosis fungoides, a type of skin lymphoma.

Patient Parameters

Program Overview

The purpose of this study is to find out if using ultra-low-dose total-skin electron beam therapy (ULD-TSEBT) together with the drug brentuximab vedotin can effectively manage mycosis fungoides, a type of skin cancer. Researchers aim to determine how well this combination works in patients with different stages of the disease and to assess the safety and side effects of the treatment. The study will also look at how long patients remain free from disease progression and their overall survival rates over a period of two and a half years.

Description

The main goal of this study is to see how well the combination of ultra-low-dose total-skin electron beam therapy and brentuximab vedotin works in treating patients with mycosis fungoides, a type of skin lymphoma. Researchers will measure the overall response rate to this treatment and monitor how long it takes for the treatment to stop working. They will also evaluate the safety of the treatment and any side effects, such as nerve damage, using standard medical guidelines. Additionally, the study will assess patients' quality of life and track their complete response rate, progression-free survival, and overall survival over two and a half years.

The study will also explore the relationship between the treatment's effectiveness and the level of a specific protein called CD30 in the cancer cells. Researchers will look for markers in the tumor and blood that might predict how well patients respond to the treatment. They will also study changes in the immune system's response to the cancer and how these changes relate to patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with mycosis fungoides in stages I-IV, with less than 1000 Sezary cells per microliter in the blood at enrollment.
  • Cancer must express at least 1% of the CD30 protein.
  • Previous cancer treatments must have been stopped at least one week before starting the study treatment.
  • Blood counts must have recovered from any previous chemotherapy.
  • Stable use of low-dose steroids is allowed if stopping them would cause harm.
  • Must be 18 years or older.
  • Must have a performance status score of 3 or less, indicating the ability to perform daily activities with some limitations.
  • No required waiting period after previous treatments.
  • HIV-positive participants must be on stable antiretroviral therapy with a CD4 count over 200.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot use other cancer treatments or steroids unless for diagnosed adrenal insufficiency.
  • Cannot have moderate to severe nerve damage.
  • Cannot have severe kidney or liver problems.
  • Women of childbearing potential must have a negative pregnancy test and use effective birth control during the study.
  • Cannot have received treatment for another primary cancer, except certain lymphomas.
  • Cannot have serious medical conditions that would interfere with treatment.
  • Cannot use certain medications that affect the study drug's effectiveness.

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