Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides

Mycosis Fungoides Clinical Trial

Official title:

Ultra Low Dose Radiation for Local Treatment of Cutaneous Mycosis Fungoides

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03398161
• Other study ID #: 2017-0276
• Secondary ID: NCI-2018-0086120
• Status: Recruiting
• Phase: Phase 2
• Start date: January 6, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Bouthaina Dabaja, MD
• Phone: 713-563-2300
• Email: bdabaja[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Localized Skin Lesion
• Mycoses
• Mycosis Fungoides

Intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Radiation:
• Radiation Therapy
Undergo ultra low dose radiation therapy

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local cutaneous control	Defined as local control of the treated lesion within the radiation treatment field, which will be categorized as either complete response or partial response of the lesion within the radiation treatment field. The control rate will be estimated along with 95% confidence intervals. The association between control rate and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate. For each patient, the number of lesions under control will be summarized individually. Since there may be multiple lesions per patient, a generalized linear mixed model will be utilized to assess the clinical factor effect (e.g. previous therapies) on control rate after considering the dependence among the lesions within each patient.	At 12 (+/-2) weeks after initial treatment
Secondary	Stable disease, progressive disease, or local regional control (local control within the radiation field margin but not encompassing the original treated lesion)	Will be described with frequency tables.	Up to 2 years
Secondary	Overall survival	Will be described with frequency tables. Will be conducted using the Kaplan Meier Method.	From initiation of treatment until death, assessed up to 2 years
Secondary	Progression free survival	Will be described with frequency tables. Will be conducted using the Kaplan Meier Method.	From treatment until progression or death, assessed up to 2 years
Secondary	Frequency/severity of skin toxicity	Defined by patient reported symptom surveys. Toxicity type (acute or chronic), severity and attribution will be summarized for each patient using frequency tables. Different time points (e.g. pre and post-treatment) will be compared using a paired t-test or Wilcoxon signed rank test as appropriate.	Up to 14 weeks
Secondary	Microbiome analysis	Will be described with frequency tables.	Up to 2 years
Secondary	Quality of life	Will be assessed by the Skindex-16 survey. Will be summarized by domains. Different time points (e.g. pre and post-treatment) will be compared using a paired t-test or Wilcoxon signed rank test as appropriate.	Up to 2 years

External Links

•   University of Texas MD Anderson Cancer Center Website