Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides

NCT03398161 | Recruiting Phase 2

• 3 other identifiers: 2017-0276NCI-2018-00861P30CA016672
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mycosis Fungoides; Localized Skin Lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Stable disease, progressive disease, or local regional control (local control within the radiation field margin but not encompassing the original treated lesion)

  Up to 2 years

• Overall survival

  From initiation of treatment until death, assessed up to 2 years

• Progression free survival

  From treatment until progression or death, assessed up to 2 years

• Frequency/severity of skin toxicity

  Up to 14 weeks

• Microbiome analysis

  Up to 2 years

Study Arms (1)

Treatment (ultra low dose radiation therapy)

EXPERIMENTAL

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

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (ultra low dose radiation therapy)

Questionnaire Administration OTHER

Ancillary studies

Treatment (ultra low dose radiation therapy)

Radiation Therapy RADIATION

Undergo ultra low dose radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation

Treatment (ultra low dose radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Mycosis Fungoides

Interventions

Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Study Officials

• Bouthaina S Dabaja

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bouthaina Dabaja, MD

CONTACT

713-563-2300; bdabaja@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 12, 2018
• Study Start: January 6, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)