Clinical trial NCT02702310: Low-Dose Total Skin Electron Therapy in Treating Patients With Refractory or Relapsed Stage IB-IIIA Mycosis Fungoides
Official title: Prospective Observational Trial of Low-Dose Total Skin Electron Therapy in Mycosis Fungoides Using Rotisserie Technique
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Recurrent Mycosis Fungoides
Refractory Mycosis Fungoides
Stage I Mycosis Fungoides
Stage II Mycosis Fungoides
Stage III Mycosis Fungoides
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The high volume of cutaneous lymphoma patients seen at Vanderbilt makes it likely to significantly contribute to the knowledge about this treatment technique. Given the rarity of this disease, with Vanderbilt being a major treatment center for mycosis fungoides, the goal is to systematically contribute to the data for low-dose total skin electron therapy in order to prospectively assess these endpoints. It is expected to find skin manifestations of mycosis fungoides that are refractory or have relapsed on at least one prior therapy. Patients with prior skin electron therapy, including either high or low-dose total skin electron therapy, are permitted on this protocol if the radiation oncologist determines that low-dose radiation therapy can safely carried out. The goal is to assess quality of life and accurately grade skin findings following this non-experimental, standard of care, total skin electron radiation treatment.

Brief summary: This clinical trial studies low- dose total skin electron therapy in treating patients with stage IB-IIIA mycosis fungoides that has not responded to previous treatment (refractory) or has returned after a period of improvement (relapsed). Radiation therapy uses high energy electrons to kill tumor cells and shrink tumors. Rotisserie technique is a method in which the patient receives total skin electron therapy while standing on a rotating platform. Giving low dose total skin electron therapy using rotisserie technique may kill tumor cells, while having fewer side effects, and may allow therapy to be repeated in future if clinically indicated.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the skin-related quality of life using an established method (Skindex-29), with comparisons made between pre-treatment and each of follow-up post-treatment skin assessments.

II. To assess the durability of response using an established method (modified Severity-Weight Assessment \[mSWAT\] tool), with comparisons made between pre-treatment and each of follow-up post-treatment skin assessments.

III. To determine side effect profile for low dose total skin electron therapy (TSE) for mycosis fungoides administered via rotisserie technique.

OUTLINE:

The investigational portion of this research study involves collecting quality of life (QOL) questionnaire data and objective measurements of patients' skin responses, which are obtained by the radiation oncologist during the patient's standard of care radiation treatment planning. Patients will also undergo standard of care low-dose total skin electron therapy for under 1 hour daily on days 10-21.

After completion of study treatment, patients are followed up at 6 and 12 weeks, and then every 3 months thereafter.

Eligibility criteria: Inclusion Criteria:

* Biopsy confirmed mycosis fungoides stage IB-IIIA
* Skin manifestations of mycosis fungoides that are refractory to or have relapsed on at least one prior therapy, which may include topical steroids
* Life expectancy \> 6 months

Exclusion Criteria:

* Serious medical condition that would make treatment unsafe
* Pregnant or lactating patient

Primary outcomes:
measure: Change in skin-related quality of life assessed by Skindex-29
timeFrame: Baseline to up to 3 years
Secondary outcomes:
measure: Change in the durability of response assessed by mSWAT tool
timeFrame: Baseline to up to 3 years
measure: Incidence of side effects of low dose total skin electron therapy administered via rotisserie technique
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Austin Kirschner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Newman NB, Patel CG, Ding GX, Zic JA, Zwerner J, Osmundson EC, Kirschner AN. Prospective observational trial of low-dose skin electron beam therapy in mycosis fungoides using a rotational technique. J Am Acad Dermatol. 2021 Jul;85(1):121-127. doi: 10.1016/j.jaad.2020.12.023. Epub 2020 Dec 14.