Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides

Launched by M.D. ANDERSON CANCER CENTER · Jan 8, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at how effective ultra low dose radiation therapy is for treating patients with mycosis fungoides, a type of skin cancer. Radiation therapy uses high-energy X-rays to target and kill cancer cells, and the aim of using ultra low doses is to manage the disease while minimizing side effects compared to standard higher doses. The trial is currently recruiting participants aged 65 to 74, and it's open to all genders.

To be eligible for this study, participants need to have a confirmed diagnosis of mycosis fungoides with at least one skin lesion that can be measured. The lesions must be small, measuring 1 cm or less in height, and all stages of the disease are welcome as long as radiation therapy is a treatment option. Participants can expect to receive the ultra low dose radiation treatment and will be monitored throughout the trial. It's important to note that pregnant individuals cannot participate, and those with certain skin conditions or larger lesions are also excluded. This trial offers a potential new approach to managing mycosis fungoides while aiming to reduce side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with pathologically confirmed MF with cutaneous involvement.
• • Patients must have clinically measurable disease of at least 1 lesion on physical (skin) exam.
• • If a patient has a prior pathological diagnosis of MF and is clinically diagnosed with a new lesion, the new lesion is eligible for enrollment without additionally biopsy confirmation.
• • Lesions of any surface span as long as =\< 1 cm in maximal height measured from the skin surface for which local control is desired are eligible; a single patient may have multiple eligible lesions that are individually enrolled for the study.
• • All stages of disease (IA through IVB) where radiation therapy is being considered for local control are eligible. Patients who are concomitantly undergoing systemic therapy for more advanced stage disease are eligible.
• • Patients who are concomitantly undergoing systemic therapy for more advanced stage disease are eligible.
• • Female patients of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin \[hCG\]) within 2 weeks of protocol entry if the patient is unsure of their pregnancy status. Patient signature declaring that they are not pregnant on the informed consent for treatment that is used in the Department of Radiation Oncology is also an acceptable substitution for a serum pregnancy test.
• • Patients who are receiving or are planned to start topical chemotherapeutics, retinoids or imiquimod to other lesions that are not planned for enrollment are eligible; however, the lesion being considered for enrollment should not be under active therapy with these topical agents immediately prior to enrollment.
• • Use of topical chemotherapeutics, retinoids or imiquimod on the lesion that is a candidate for enrollment must be halted at least 24 hours prior to enrollment in the study.
• Exclusion Criteria:
• • Pregnant patients do not meet inclusion criteria for radiation therapy.
• • Patients who subsequently become pregnant may continue follow up within the protocol, but a negative urine pregnancy test will need to be obtained before additional lesions may be enrolled.
• • Patients with active lupus or scleroderma
• • Lesions with a height \> 1 cm measured from the skin surface are not eligible for this protocol.