Study on Ultra Low Dose Radiation Therapy for Treating Mycosis Fungoides

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03398161

Provider View

This clinical trial is exploring the effectiveness of using ultra low doses of radiation therapy to treat patients with mycosis fungoides, a type of skin lymphoma. The aim is to control the disease while minimizing side effects compared to higher radiation doses.

Patient Parameters

Program Overview

This phase II study is investigating how well ultra low dose radiation therapy works in treating patients with mycosis fungoides, a type of skin cancer. Radiation therapy uses high-energy x-rays to kill cancer cells and shrink tumors. By using ultra low doses, the study aims to control the disease and reduce side effects compared to higher doses of radiation.

Description

The main goal of this study is to see how effective low dose radiation is in managing mycosis fungoides, a type of skin cancer, by checking if the cancer is controlled at the treated site 12 weeks after treatment. Other goals include evaluating how many patients have a complete response, how long the response lasts, overall survival, progression-free survival, symptom relief, and any skin side effects from the radiation. The study will also look at whether the number of previous treatments affects the response and will examine the skin's microbiome before and after radiation therapy.

Patients will receive ultra low dose radiation therapy as decided by their doctor. After treatment, patients will have follow-up visits at 4-6 weeks, 10-14 weeks, every 3 months for 6-8 months, and then every 6-12 months for up to 2 years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of mycosis fungoides with skin involvement.
  • Must have at least one measurable skin lesion.
  • New lesions can be included without a new biopsy if previously diagnosed with mycosis fungoides.
  • Lesions must be 1 cm or less in height from the skin surface.
  • All stages of the disease (IA to IVB) are eligible if radiation is considered for local control.
  • Patients receiving systemic therapy for advanced disease can participate.
  • Women of childbearing potential must have a negative pregnancy test or declare they are not pregnant.
  • Patients using topical treatments on other lesions can participate, but the lesion for the study must not be under active treatment with these agents immediately before joining the study.

Exclusion Criteria

  • Pregnant patients cannot participate in radiation therapy.
  • Patients who become pregnant can continue follow-up but need a negative pregnancy test before enrolling new lesions.
  • Patients with active lupus or scleroderma cannot participate.
  • Lesions taller than 1 cm from the skin surface are not eligible.

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