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Radiation Therapy

Low-Dose Radiation Therapy for Mycosis Fungoides

Phase 2
Recruiting
Led By Bouthaina S Dabaja
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with pathologically confirmed MF with cutaneous involvement
Patients must have clinically measurable disease of at least 1 lesion on physical (skin) exam
Must not have
Patients with active lupus or scleroderma
Lesions with a height > 1 cm measured from the skin surface are not eligible for this protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at using low doses of radiation to treat mycosis fungoides. The hope is that it will be more effective than higher doses with fewer side effects.

Who is the study for?
This trial is for patients with mycosis fungoides, a type of skin lesion. Eligible participants can have any stage of the disease and may be undergoing other treatments. They must not apply certain topical agents to the lesion before joining, and women who can become pregnant need a negative pregnancy test.
What is being tested?
The study tests ultra low dose radiation therapy's effectiveness in treating mycosis fungoides. It aims to control the disease with fewer side effects than higher doses. Patients' quality of life will also be assessed through questionnaires.
What are the potential side effects?
While specific side effects are not listed, ultra low dose radiation may include skin irritation, fatigue, mild swelling or redness at treatment sites compared to higher doses which often cause more severe reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have mycosis fungoides with skin symptoms.
Select...
I have at least one visible tumor that can be measured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have active lupus or scleroderma.
Select...
My skin lesions are not taller than 1 cm from the surface.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Local cutaneous control
Secondary study objectives
Frequency/severity of skin toxicity
Microbiome analysis
Overall survival
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ultra low dose radiation therapy)Experimental Treatment3 Interventions
Patients undergo ultra low dose radiation therapy at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,037 Total Patients Enrolled
105 Trials studying Mycosis Fungoides
4,301 Patients Enrolled for Mycosis Fungoides
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,297 Total Patients Enrolled
10 Trials studying Mycosis Fungoides
399 Patients Enrolled for Mycosis Fungoides
Bouthaina S DabajaPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
395 Total Patients Enrolled

Media Library

Ultra Low Dose Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03398161 — Phase 2
Mycosis Fungoides Research Study Groups: Treatment (ultra low dose radiation therapy)
Mycosis Fungoides Clinical Trial 2023: Ultra Low Dose Radiation Therapy Highlights & Side Effects. Trial Name: NCT03398161 — Phase 2
Ultra Low Dose Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03398161 — Phase 2
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