A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides

Официальное название

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

Обзор

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).

Вмешательства

• Препарат Bexarotene
  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.
• Лучевая терапия Total 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).

Первичные конечные точки

• Incidence of radiation dermatitis grade 3+ [Срок оценки: 1 month post-treatment]

Вторичные конечные точки (1)

• Overall skin response rate [Срок оценки: up to 82 days post-TSEB]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

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

Идентификаторы

NCT: NCT05296304 · 21-501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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