Ultra Low Dose Radiation for Local Treatment of Cutaneous Mycosis Fungoides

Who is this study for? Patients with Localized Skin Lesion, Mycosis Fungoides
What treatments are being studied? Quality-of-Life Assessment+Questionnaire Administration+Radiation Therapy
Status: Recruiting
Location: See location...
Intervention Type: Other, Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Bouthaina Dabaja, MD
bdabaja@mdanderson.org
713-563-2300
Time Frame
Start Date: 2018-01-06
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 50
Treatments
Experimental: Treatment (ultra low dose radiation therapy)
Patients undergo ultra low dose radiation therapy at the discretion of the treating physician.
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov