Combining bexarotene with radiotherapy for treating mycosis fungoides

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and effectiveness of combining bexarotene, a vitamin A derivative, with Total Skin Electron Beam (TSEB) radiotherapy in patients diagnosed with mycosis fungoides, a common form of cutaneous T-cell lymphoma. The approach is based on the hypothesis that simultaneous treatment with both therapies may enhance cancer cell destruction compared to administering them separately. Participants will be monitored for safety and response to the combined treatment regimen.

Why it matters

Who can join: the full rules

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

Where it's running

• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting
• Memorial Sloan Kettering Nassau (Limited Protocol Activites)
  Rockville Centre, New York, United States Recruiting

Study contacts

• Principal investigator: Brandon Imber, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Brandon Imber, MD, MS
• Email: imberb@mskcc.org
• Phone: 631-212-6346

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.