Combining bexarotene with radiotherapy for treating mycosis fungoides
A Phase Ib Trial Combining Bexarotene With Ultra-Low Dose Total Skin Electron Beam (Tseb) Radiotherapy For The Treatment Of Diffuse Cutaneous T-Cell Lymphomas
This study is testing if combining a medication called bexarotene with a type of radiation therapy can help people with mycosis fungoides, a skin cancer, feel better and improve their treatment results.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Commack, New York and 2 other locations) |
| Trial ID | NCT05296304 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed mycosis fungoides at stage IB or higher.
Not a fit: Patients who have received prior TSEB treatment or those with concurrent systemic anaplastic large cell lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could provide a more effective option for patients with mycosis fungoides, potentially improving their outcomes.
How similar studies have performed: While the combination of bexarotene and TSEB is a novel approach, previous studies have shown promise in using these treatments individually for cutaneous T-cell lymphoma.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Commack, New York and 2 other locations
- 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
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.