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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Ultra Low Dose Radiation Therapy for Mycosis Fungoides?

Research shows that low-dose radiation therapy is effective for treating mycosis fungoides, especially in early stages or for localized lesions. It can provide excellent response and control for non-tumoral lesions, and even in advanced cases, it has shown significant improvement in some patients. ^{1 2 3 4 5}

Is low-dose radiation therapy safe for treating mycosis fungoides?

Low-dose radiation therapy for mycosis fungoides has been shown to have a good safety profile, with most adverse events being mild. Studies indicate that it is generally well-tolerated, with minimal severe side effects, making it a safe option for patients. ^{3 4 6 7 8}

How does Ultra Low Dose Radiation Therapy differ from other treatments for mycosis fungoides?

Ultra Low Dose Radiation Therapy uses a very low dose of radiation, specifically 2 fractions of 4 Gy delivered over two days, which is different from other treatments like total skin electron beam therapy that use higher doses over a longer period. This approach is particularly effective for non-tumoral lesions, offering excellent response and control, but is less effective for tumoral lesions compared to other higher-dose therapies. ^{4 9 10 11 12}

Research Team

Bouthaina S Dabaja

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

Pregnant patients do not meet inclusion criteria for radiation therapy

I have active lupus or scleroderma.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Localized conventional radiotherapy in the treatment of Mycosis Fungoides: our experience in 100 patients. [2014]

2. France pubmed.ncbi.nlm.nih.gov

Mycosis fungoides. Electron beam therapy. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Radiation Therapy for Cutaneous T-Cell Lymphomas. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Response and local control in patients treated with low-dose radiotherapy for tumoral mycosis fungoides. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Rapidly progressive stage IVB mycosis fungoides treated with low-dose total skin electron beam therapy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Short-term efficacy and safety of total skin electron beam therapy in mycosis fungoides: Systematic review and meta-analysis. [2022]

7. Sweden pubmed.ncbi.nlm.nih.gov

Low- vs. Middle-dose Total Skin Electron Beam Therapy for Mycosis Fungoides: An Efficiency-based Retrospective Survey of Skin Response. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Low dose total skin electron beam therapy for the management of T cell cutaneous lymphomas. [2021]

9. France pubmed.ncbi.nlm.nih.gov

[Total cutaneous electron beam therapy of mycosis fungoides]. [2006]

10. Italy pubmed.ncbi.nlm.nih.gov

[Total cutaneous irradiation with low energy electrons and mycosis fungoides. Technic and dosimetry]. [2008]

11. United States pubmed.ncbi.nlm.nih.gov

Whole body surface electron irradiation in the treatment of mycosis fungoides. An evaluation of 200 patients. [2007]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Total skin electron irradiation in mycosis fungoides. [2019]