RecruitingPhase 1NCT05296304

A Study of Bexarotene Combined With Radiotherapy in People With 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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

20 participants

Start Date

Mar 16, 2022

Study Type

INTERVENTIONAL

Conditions

Cutaneous T Cell Lymphoma

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 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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining a drug called bexarotene with targeted radiation therapy (to a specific skin lesion) can trigger a broader immune response against mycosis fungoides — a type of lymphoma that primarily affects the skin. **You may be eligible if...** - You are 18 or older - You have been diagnosed with mycosis fungoides confirmed by skin biopsy at the study center - Your disease is stage IB or higher - You have a baseline skin disease score (mSWAT) of at least 10 - You are in good general health (ECOG 0–2) - Both newly diagnosed and previously treated patients are eligible **You may NOT be eligible if...** - You are currently taking any oral retinoid medications - You have significant liver, kidney, or heart problems - You have uncontrolled thyroid conditions or abnormal blood fat (triglyceride) levels - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBexarotene

Orally 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.

RADIATIONTotal Skin Electron Beam (TSEB)

At Day 21, if the bexarotene has shown to be tolerated, patients will receive the first dose of TSEB (2 Gy x 2).

Locations(3)

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05296304

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