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

Conditions

• Cutaneous T-cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bexarotene — DRUG
  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.
• Total Skin Electron Beam (TSEB) — RADIATION
  At Day 21, if the bexarotene has shown to be tolerated, patients will receive the first dose of TSEB (2 Gy x 2).

Study Details

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).

Key Dates

Start date

Mar 16, 2022

Status verified

Feb 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Bexarotene Combined With Radiotherapy
  Patients will be initiated on bexarotene 150 mg daily on Day 1, with dose increase to 300 mg daily on Day 15. Patients will receive Cycle 1 of TSEB on Day 22 (with 2 Gy given on two consecutive days -Day 22 and 23), with safety assessment on Day 52. Efficacy will first be assessed on Day 52 and then again on Day 82 by global response assessment, including mSWAT. Patients who have less than 70% reduction from baseline mSWAT score will be eligible for subsequent cycles of TSEB (administered as 4 Gy over 2 consecutive days), until mSWAT score reduction of ≥ 70%, and up to a total of 6 cycles. Treatment may continue until disease progression, unacceptable toxicity, recommended termination by treating physician, or termination of the study.

Primary Outcome Measure

Incidence of radiation dermatitis grade 3+ [ Time Frame: 1 month post-treatment ]

Central Contacts

• Brandon Imber, MD, MS
  631-212-6346
  [email protected]
• Shamir Geller
  [email protected]

Locations (3)

Find similar trials in Commack, NY

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