Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides

Official title

Ultra Low Dose Radiation for Local Treatment of Cutaneous Mycosis Fungoides

Overview

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.

Detailed 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.

Interventions

• Other Quality-of-Life Assessment
  Ancillary studies
• Other Questionnaire Administration
  Ancillary studies
• Radiation Radiation Therapy
  Undergo ultra low dose radiation therapy

Primary outcome measures

• Local cutaneous control [Time frame: At 12 (+/-2) weeks after initial treatment]

Secondary outcome measures (6)

• Stable disease, progressive disease, or local regional control (local control within the radiation field margin but not encompassing the original treated lesion) [Time frame: Up to 2 years]
• Overall survival [Time frame: From initiation of treatment until death, assessed up to 2 years]
• Progression free survival [Time frame: From treatment until progression or death, assessed up to 2 years]
• Frequency/severity of skin toxicity [Time frame: Up to 14 weeks]
• Microbiome analysis [Time frame: Up to 2 years]
• Quality of life [Time frame: Up to 2 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT03398161 · 2017-0276 · NCI-2018-00861 · 2017-0276 · P30CA016672

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗