Vitamin a derivative paired with Low-Dose radiation shows promise for rare skin cancer
NCT ID NCT05296304
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests the safety of combining bexarotene (a vitamin A-like drug) with ultra-low dose total skin electron beam radiotherapy for people with mycosis fungoides, a common form of cutaneous T-cell lymphoma. About 20 adults with stage IB or higher disease will receive both treatments at the same time. The goal is to see if this combination is safe and possibly more effective than either treatment alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2022
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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) Prohibited concurrent medications * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cutaneous T-cell lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
3 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITINGNew York, New York, 10065, United States
-
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
RECRUITINGRockville Centre, New York, 11553, United States
-
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Pairing a steroid with lymphoma gel may prevent painful skin reactions
- Can an eczema cream fight a rare skin cancer?
- A microchip implanted in tumors could reveal which drugs work best
- Skin gel targets immune signals in rare lymphoma
- Can a tailored exercise and diet plan beat cancer fatigue?
- New cream targets skin lymphoma without steroids