Status:
RECRUITING
A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Cutaneous T-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05296304
Start Date
March 16 2022
End Date
March 1 2026
Last Update
November 10 2025
Active Locations (3)
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1
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
2
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
3
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States, 11553