Low-Dose Radiation Therapy for Mycosis Fungoides

Overseen By Bouthaina S. Dabaja

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Lupus, Scleroderma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of ultra low dose radiation therapy for treating mycosis fungoides, a type of skin lymphoma. The aim is to determine if lower doses of radiation can control the disease while causing fewer side effects than higher doses. It targets patients with mycosis fungoides who have at least one visible skin lesion. Lesions must be less than 1 cm in height, and patients may have multiple eligible lesions. Those already receiving other treatments for advanced disease can still participate. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using topical treatments like chemotherapeutics, retinoids, or imiquimod on the lesion being studied, you must stop at least 24 hours before joining the trial.

Is there any evidence suggesting that ultra low dose radiation therapy is likely to be safe for humans?

Research has shown that ultra-low dose radiation therapy is generally easy for patients to handle. In one study, patients experienced some side effects, mostly mild. About half of the patients had moderate side effects, which were manageable. Only one patient experienced a more serious side effect, but this was rare. Overall, these findings suggest that the treatment is safe for most people.

Another study on similar low-dose radiation treatments found that most patients did not experience severe side effects shortly after treatment, indicating excellent short-term safety. This makes ultra-low dose radiation therapy a promising option for managing mycosis fungoides with fewer risks compared to higher radiation doses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for mycosis fungoides?

Ultra low dose radiation therapy is unique because it offers a gentler approach to treating mycosis fungoides, a type of skin lymphoma. Unlike standard treatments like topical steroids, phototherapy, or higher doses of radiation, this therapy uses much lower doses of radiation, potentially reducing side effects while still effectively targeting cancer cells. Researchers are excited because it could mean fewer negative impacts on healthy skin and an improved quality of life for patients. This novel approach might offer a promising alternative for those seeking effective yet less aggressive treatment options.

What evidence suggests that ultra low dose radiation therapy might be an effective treatment for mycosis fungoides?

Research has shown that ultra low dose radiation therapy, which participants in this trial will receive, can effectively treat mycosis fungoides, a type of skin cancer. Studies have found that between 36% and 96% of patients experience symptom reduction with this treatment. Specifically, one study found that about 88.9% of patients saw symptom improvement, indicating many patients benefited from the therapy. Importantly, this treatment usually causes fewer severe side effects than higher doses. This suggests that ultra low dose radiation therapy may offer a good balance of effectiveness and safety for managing the disease. ^{1 3 4 5 6}

Who Is on the Research Team?

Bouthaina S Dabaja

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have mycosis fungoides with skin symptoms.

I have at least one visible tumor that can be measured.

My cancer lesions are less than or equal to 1 cm tall and I want them treated.

Exclusion Criteria

I have active lupus or scleroderma.

Pregnant patients do not meet inclusion criteria for radiation therapy

My skin lesions are not taller than 1 cm from the surface.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

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

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Follow-up at 4-6 and 10-14 weeks, every 3 months for 6-8 months, then every 6-12 months

What Are the Treatments Tested in This Trial?

Interventions

• Ultra Low Dose Radiation Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (ultra low dose radiation therapy) Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a retrospective study of 100 patients with Mycosis Fungoides, localized superficial radiotherapy achieved a high complete remission rate of 88%, demonstrating its efficacy as a treatment option.

The treatment was well tolerated with good cosmetic outcomes in 93% of cases, and the local control rate was 85% after 5 years, indicating that localized radiotherapy is both effective and safe for managing this skin condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Localized conventional radiotherapy in the treatment of Mycosis Fungoides: our experience in 100 patients. Piccinno, R., Caccialanza, M., Çuka, E., et al.[2014]

A case study of a 50-year-old male with rapidly progressive stage IVB mycosis fungoides showed a remarkable 95% response to low-dose total skin electron beam (TSEB) therapy (24 Gy over 8 weeks) with no apparent side effects, highlighting its potential efficacy even in advanced disease.

The patient has remained in remission for over 4 years after treatment, suggesting that low-dose TSEB can be a viable option for managing advanced-stage mycosis fungoides, which is typically considered palliative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapidly progressive stage IVB mycosis fungoides treated with low-dose total skin electron beam therapy. Chowdhary, M., Kabbani, AA., Rimtepathip, P., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7128043/

Ultra-Low-Dose Radiotherapy for Palliation of Mycosis ... In advanced MF, the remission of symptoms has been reported in 36–96% of these treatments [6, 7]. Despite the promising results, an important ...

2. ascopubs.org ascopubs.org/doi/10.1200/OA-25-00065

Low-Dose Total Skin Electron Beam Radiotherapy in Stage ... There was no significant difference in outcome between the radiation regimens. Only 17% reported grade 2 toxicities, and the rate of grade 3 or ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05357794

NCT05357794 | Effectiveness of Concurrent Ultra-Low ... The primary objective is to determine the overall response rate (ORR), to ultra-low-dose-total-skin electron beam therapy with brentuximab vedotin (ULD-TSEBT+BV) ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301623002158

Ultrahypofractionated Low-Dose Total Skin Electron Beam ... The overall response rate was 88.9% (95% confidence interval [CI], 65.3-98.6), with 3 complete responses (16.9%; 95% CI, 3.6-41.4). At a median ...

5. ejcancer.com ejcancer.com/article/S0959-8049(24)01030-X/fulltext

Radiotherapy in cutaneous lymphomas Reduced-dose RT is highly effective for patients with indolent types. RT enhances the QoL in many patients with primary cutaneous lymphoma. ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9786352/

Short‐term efficacy and safety of total skin electron beam ... TSEBT is an associated with an excellent short term safety profile. Both schedules show high ORR, with standard dose TSEBT demonstrating highest CRR.