The researchers are doing this study to test the safety of combining bexarotene with TSEB radiotherapy in people who have a common form of CTCL called mycosis fungoides (MF).
Bexarotene is a form of vitamin A that activates proteins called retinoid X receptors, which may stop the growth of cancer cells and kill them. TSEB radiotherapy is a type of radiation therapy that treats the entire surface of the skin with very low doses of radiation to kill cancer cells and shrink tumors. This type of radiation does not pass through the outer layers of the skin into the tissues and organs below the skin.
The study researchers think that giving bexarotene treatment at the same time as treatment with TSEB radiotherapy may be more effective against MF than either treatment given alone or in sequence (one after the other).
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
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
Single group
Bexarotene
DrugOrally every day starting at the dose of 150 mg/day flat dose. At Day 15, if the treatment is tolerated, patients will escalate the dose of bexarotene to 300 mg/day, and that dose will remain constant during the rest of the study.
Total Skin Electron Beam (TSEB)
RadiationAt Day 21, if the bexarotene has shown to be tolerated, patients will receive the first dose of TSEB (2 Gy x 2).
Incidence of radiation dermatitis grade 3+
as defined by number of patients who develop CTCAE, v. 5, grade 3+ toxicities at 1 month post-treatment.
Overall skin response rate
For patients with mycosis fungoides without blood involvement, the response criteria will be based upon modified international consensus guidelines.26 Specifically, skin response will be assessed by the Modified Severity Weighted Assessment Tool (mSWAT). For the purposes of this protocol, overall skin response will be considered to be either CR or PR.
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