Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides

Phase

Condition

Mycosis Fungoides

Lymphoproliferative Disorders

Treatment

Radiation Therapy

Questionnaire Administration

Quality-of-Life Assessment

Clinical Study ID

NCT03398161

2017-0276

P30CA016672

NCI-2018-00861

2017-0276

Ages > 18
All Genders

Study Summary

This phase II trial studies how well ultra low dose radiation therapy works in treating patients with mycosis fungoides. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving ultra low doses of radiation may help control the disease and reduce side effects compared to treatment with higher doses.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients with pathologically confirmed MF with cutaneous involvement.
Patients must have clinically measurable disease of at least 1 lesion onphysical (skin) exam.
If a patient has a prior pathological diagnosis of MF and is clinicallydiagnosed with a new lesion, the new lesion is eligible for enrollment withoutadditionally biopsy confirmation.
Lesions of any surface span as long as =< 1 cm in maximal height measured from theskin surface for which local control is desired are eligible; a single patient mayhave multiple eligible lesions that are individually enrolled for the study.
All stages of disease (IA through IVB) where radiation therapy is being consideredfor local control are eligible. Patients who are concomitantly undergoing systemictherapy for more advanced stage disease are eligible.
Patients who are concomitantly undergoing systemic therapy for more advanced stagedisease 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 thepatient is unsure of their pregnancy status. Patient signature declaring that theyare not pregnant on the informed consent for treatment that is used in theDepartment of Radiation Oncology is also an acceptable substitution for a serumpregnancy test.
Patients who are receiving or are planned to start topical chemotherapeutics,retinoids or imiquimod to other lesions that are not planned for enrollment areeligible; however, the lesion being considered for enrollment should not be underactive therapy with these topical agents immediately prior to enrollment.
Use of topical chemotherapeutics, retinoids or imiquimod on the lesion that isa candidate for enrollment must be halted at least 24 hours prior to enrollmentin the study.

Exclusion

Exclusion Criteria:

Pregnant patients do not meet inclusion criteria for radiation therapy.
Patients who subsequently become pregnant may continue follow up within theprotocol, but a negative urine pregnancy test will need to be obtained beforeadditional lesions may be enrolled.
Patients with active lupus or scleroderma
Lesions with a height > 1 cm measured from the skin surface are not eligible forthis protocol.

Study Design

Radiation Therapy

January 06, 2018

December 31, 2027

Study Description

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of low dose radiation in the management of cutaneous mycosis fungoides (MF), measured as any local control for each lesion at 12 (+/- 2) weeks after the treatment, in patients with stage IA - IVB cutaneous MF.

SECONDARY OBJECTIVES:

I. To evaluate complete response (CR) rates at 12 (+2) weeks and beyond.

II. To evaluate the persistence of response (CR, partial response [PR], stable disease, or progressive disease) in the treated lesion beyond 12 (+2) weeks.

III. To evaluate overall survival.

IV. To evaluate progression free survival.

V. To evaluate patient symptom relief.

VI. To evaluate the toxicity of radiation to the skin.

VII. To assess if number of previous therapies including chemotherapy, targeted therapy, topical therapy, or total skin radiation affects the response.

VIII. To characterize the microbiome of mycosis fungoides patient within both the lesion and unaffected skin.

IX. To characterize shifts in the microbiome that occur after radiation therapy.

OUTLINE:

Patients undergo ultra low dose radiation therapy at the discretion of the treating physician.

After completion of study treatment, patients are followed up at 4-6 and 10-14 weeks, every 3 months for 6-8 months, then every 6-12 months for up to 2 years.

Connect with a study center

M D Anderson Cancer Center
Houston, Texas 77030
United States
Site Not Available
M D Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United States
Active - Recruiting

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