Ultra low dose radiation therapy for mycosis fungoides
Ultra Low Dose Radiation for Local Treatment of Cutaneous Mycosis Fungoides
This study is testing if a very low dose of radiation therapy can effectively treat mycosis fungoides, a type of skin lymphoma, and help patients with different stages of the disease feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03398161 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of ultra low dose radiation therapy in treating patients with mycosis fungoides, a type of skin lymphoma. The study aims to evaluate local control of skin lesions, complete response rates, and overall survival among patients with varying stages of the disease. Participants will receive radiation therapy tailored by their treating physician and will be monitored for response and side effects over a period of up to two years. The trial also seeks to understand the impact of previous therapies and changes in the skin microbiome following treatment.
Who should consider this trial
Good fit: Ideal candidates include patients with pathologically confirmed mycosis fungoides who have measurable skin lesions and are at any stage of the disease.
Not a fit: Patients with advanced mycosis fungoides requiring systemic therapy rather than localized treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and less toxic treatment option for patients with mycosis fungoides.
How similar studies have performed: While studies on radiation therapy exist, this specific approach of ultra low doses in mycosis fungoides is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Pregnant patients do not meet inclusion criteria for radiation therapy. * 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.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Bouthaina S Dabaja — M.D. Anderson Cancer Center
- Study coordinator: Bouthaina Dabaja, MD
- Email: bdabaja@mdanderson.org
- Phone: 713-563-2300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.