Clinical trial NCT03398161: Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides
Official title: Ultra Low Dose Radiation for Local Treatment of Cutaneous Mycosis Fungoides
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Localized Skin Lesion
Mycosis Fungoides
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Local cutaneous control
timeFrame: At 12 (+/-2) weeks after initial treatment
Secondary outcomes:
measure: Stable disease, progressive disease, or local regional control (local control within the radiation field margin but not encompassing the original treated lesion)
timeFrame: Up to 2 years
measure: Overall survival
timeFrame: From initiation of treatment until death, assessed up to 2 years
measure: Progression free survival
timeFrame: From treatment until progression or death, assessed up to 2 years
measure: Frequency/severity of skin toxicity
timeFrame: Up to 14 weeks
measure: Microbiome analysis
timeFrame: Up to 2 years
measure: Quality of life
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Bouthaina S Dabaja
role: PRINCIPAL_INVESTIGATOR
References: