Actively Recruiting
A Phase Ib Trial Combining Bexarotene With Ultra-Low Dose Total Skin Electron Beam Radiotherapy for Diffuse Cutaneous T-Cell Lymphomas
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-04
20
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of combining bexarotene with total skin electron beam (TSEB) radiotherapy in people with mycosis fungoides (MF), a common form of cutaneous T-cell lymphoma (CTCL). Bexarotene, a vitamin A derivative, activates proteins that may stop the growth of cancer cells, while TSEB radiotherapy treats the entire skin surface with low-dose radiation to kill cancer cells without affecting deeper tissues. The study aims to see if using both treatments together is more effective than using them separately or one after the other. Participants start with bexarotene taken orally daily at 150 mg, increasing to 300 mg on Day 15 if tolerated. On Day 22, they receive the first cycle of TSEB radiotherapy, given as 2 Gy over two consecutive days. Safety is assessed on Day 52, with efficacy evaluations on Days 52 and 82 using global response assessments including the modified Severity Weighted Assessment Tool (mSWAT). Patients with less than 70% reduction in mSWAT score may receive additional TSEB cycles of 4 Gy over two days, up to six cycles total. Treatment continues until disease progression, unacceptable side effects, physician recommendation, or study end. During the study, participants undergo safety and response evaluations including skin assessments with mSWAT scoring. The primary outcome measures the incidence of severe radiation dermatitis one month after treatment, while secondary outcomes assess overall skin response up to 82 days post-TSEB. The trial involves ongoing monitoring of treatment tolerance and disease status. Participants remain in the study until criteria for stopping treatment or study completion are met, with the expected study duration extending to March 2027.
CONDITIONS
Brief Title
A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of cutaneous T-cell lymphoma consistent with mycosis fungoides based on biopsy reviewed at MSKCC
- Stage IB or higher mycosis fungoides per ISCL/EORTC criteria; patients with Sézary syndrome also eligible
- Baseline mSWAT score of at least 10
- Stable use of topical steroids or systemic antipruritic agents before study entry; no new anti-pruritics started after enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Ability to provide informed consent
You will not qualify if you...
- Use of any oral retinoid therapy within 3 weeks before starting the study drug
- Previous total skin electron beam radiotherapy; prior focal skin-directed radiotherapy allowed
- Concurrent diagnosis of systemic anaplastic large cell lymphoma or another non-Hodgkin lymphoma
- Diagnosis of an additional non-skin malignancy
- Pregnancy
- Unwillingness to use two forms of barrier contraception during study medication
- Treatment with another investigational drug or device currently or within 2 weeks before enrollment
- Familial hypertriglyceridemia or other contraindications to bexarotene
- High likelihood of not following the study protocol (per investigator opinion)
- Use of systemic steroids within 2 weeks before the first dose of study drug, except for non-disease related conditions as allowed by investigator
- Use of gemfibrozil, which is contraindicated with bexarotene
- Avoidance of strong or moderate CYP3A4 inducers and inhibitors if possible due to interactions with bexarotene
- Avoidance of certain CYP3A4 sensitive substrates that may be affected by bexarotene, if possible, including drugs like cyclosporine and fentanyl
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to study completion or discontinuation
Participants take oral bexarotene daily starting at 150 mg, increasing to 300 mg on Day 15 if tolerated. Starting on Day 22, participants receive ultra-low dose total skin electron beam radiotherapy in cycles, with safety and efficacy assessments following each cycle. Treatment continues until disease progression, unacceptable toxicity, physician recommendation, or study end.
Multiple visits including radiation on consecutive days and follow-up assessments on Days 52 and 82; additional cycles involve 2 consecutive radiation days each
Trial Site Locations
Total: 3 locations
1
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
3
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
B
Brandon Imber, MD, MS
S
Shamir Geller
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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