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Bexarotene and Radiotherapy for Mycosis Fungoides

This study is testing the safety of combining two treatments, bexarotene and Total Skin Electron Beam (TSEB) radiotherapy, for people with mycosis fungoides (MF). MF is a common type of cutaneous T-cell lymphoma (CTCL), a cancer that starts in white blood cells and affects the skin. Bexarotene is a form of vitamin A that may help stop cancer cell growth. TSEB radiotherapy uses low-dose radiation over the entire skin surface to kill cancer cells without deeply penetrating the skin. Researchers want to see how many participants experience severe skin irritation (radiation dermatitis grade 3+) within one month after treatment. The study plans to enroll 20 adults aged 18 or older with stage IB or higher MF. The current recruitment status is unclear.

Study design
This study is an interventional trial with an unclear phase, planning to enroll 20 participants. It is testing a combination of two treatments.
What's involved
Participants will take bexarotene daily, starting at 150 mg and increasing to 300 mg if tolerated. After 21 days, if bexarotene is tolerated, participants will receive TSEB radiotherapy.
Compensation
Not stated in the trial record.
Follow-up
The primary safety outcome, severe skin irritation, will be measured one month after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05296304

A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides

Recruiting
PHASE1Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~20 participants
Updated 2026-02-04 on ClinicalTrials.gov
What's tested:BexaroteneTotal Skin Electron Beam (TSEB)

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of radiation dermatitis grade 3+
Measured over 1 month post-treatment

Conditions

Cutaneous T-cell Lymphoma

Explore related trials

Mycosis FungoidesSezary Syndrome

NCT05296304

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activites)

    Rockville Centre, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Brandon Imber, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Brandon Imber, MD, MS
[email protected]
631-212-6346
Email the study team

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Eligibility criteria

Inclusion

Age ≥18 years
Pathologically confirmed cutaneous T-cell lymphoma consistent with mycosis fungoides (MF) based on biopsy done or reviewed at MSKCC
Stage IB or higher MF per ISCL/EORTC criteria; concurrent diagnosis of Sézary syndrome permissible. Patients who have not had prior systemic therapies and refractory/relapsed patients are eligible.
Baseline mSWAT score of at least 10
Stable topical steroids or systemic antipruritic agent (e.g. antihistamines, doxepin, GABA analogs) preceding study entry is permissible, but no new prescribed or over the counter topical or systemic anti-pruritics started post-enrollment
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Ability to provide informed consent

Exclusion

Any oral retinoid therapy for any indication within 3 weeks of the first dose of study drug
Prior TSEB (prior focal skin-directed RT acceptable)
Concurrent diagnosis of systemic anaplastic large cell lymphoma (ALCL) or another non-Hodgkin lymphoma
Concurrent diagnosis of additional non-skin malignancy
Pregnancy
Patients unwilling to use two forms of barrier contraception while taking study medication
Receipt of treatment with another investigational device or drug (at present or within 2 weeks of enrollment)
Familial hypertriglyceridemia or other medical conditions in which use of bexarotene would be contraindicated
High likelihood of protocol non-compliance (in opinion of investigator)
Systemic steroids within two weeks of first dose of study drug (patients on systemic steroids for non-disease related conditions will be permitted per investigator discretion)
Gemfibrozil is contraindicated as may increase bexarotene concentrations
Bexarotene is a minor CYP3A4 substrate: avoid strong/moderate CYP3A4 inducers and inhibitors, if possible, but concomitant use is not a contraindication Bexarotene is a moderate CYP3A4 inducer: avoid concurrent administration with CYP3A4 sensitive substrates, for which minimal concentration changes may lead to therapeutic failures of the substrate (e.g. cyclosporine, tacrolimus, sirolimus, quinidine, fentanyl), if possible

What this trial measures

  • Incidence of radiation dermatitis grade 3+1 month post-treatment

    as defined by number of patients who develop CTCAE, v. 5, grade 3+ toxicities at 1 month post-treatment.