What is the mechanism of action of this treatment?

Bexarotene, a form of vitamin A, activates retinoid X receptors, which can halt the growth of cancer cells and induce their death. TSEB Radiotherapy uses low-dose radiation to target and kill cancer cells on the skin's surface without penetrating deeper tissues. These mechanisms are crucial for CTCL patients as they offer targeted treatments that can effectively reduce tumor burden and manage symptoms with potentially fewer systemic side effects compared to more invasive therapies.

What side effects are associated with this type of intervention?

Bexarotene, used in the treatment of Cutaneous T-Cell Lymphoma (CTCL), can cause side effects such as hyperlipidemia, hypothyroidism, headache, fatigue, and skin-related issues like dryness and rash. TSEB radiotherapy, which uses low-dose radiation to treat the skin, can lead to side effects including erythema (redness of the skin), dry skin, hair loss, and potential long-term risks like secondary skin cancers. These side effects are important considerations for patients and healthcare providers when deciding on a treatment plan.

What prior FDA approvals exist?

For the treatment of Cutaneous T-Cell Lymphoma (CTCL), the FDA has approved bexarotene, a retinoid that activates retinoid X receptors to inhibit cancer cell growth and induce apoptosis. Additionally, Total Skin Electron Beam (TSEB) radiotherapy is a recognized treatment that uses low-dose radiation to target and kill cancer cells on the skin surface. These treatments aim to manage and reduce the symptoms of CTCL by either directly targeting cancer cells or modulating cellular pathways to inhibit tumor growth.

What other types of research exist?

Promising novel alternatives for CTCL treatment in 2024 include: 1) Mogamulizumab, a monoclonal antibody targeting CCR4, which has shown efficacy in CTCL. 2) Brentuximab vedotin, an antibody-drug conjugate targeting CD30, approved for certain types of lymphoma including CTCL. 3) Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, which has shown promise in various lymphomas. These treatments offer targeted mechanisms of action and have demonstrated potential in clinical settings.

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Retinoid X Receptor Agonist

Bexarotene + Radiotherapy for Cutaneous T-Cell Lymphoma

Phase 1

Recruiting

Led By Sarah Noor, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Must not have

Patients unwilling to use two forms of barrier contraception while taking study medication

Concurrent diagnosis of systemic anaplastic large cell lymphoma (ALCL) or another non-Hodgkin lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety of combining bexarotene, a vitamin A derivative, with TSEB radiotherapy in patients with mycosis fungoides, a type of skin lymphoma. Bexarotene helps stop and kill cancer cells, while TSEB radiotherapy uses low-dose radiation to treat the skin. Researchers believe this combination may be more effective than using each treatment separately. Bexarotene has been used for both early and advanced cutaneous T-cell lymphoma (CTCL).

Who is the study for?

Adults with a skin lymphoma called mycosis fungoides (MF) can join this trial. They should be in relatively good health, able to consent, and have an ECOG performance status of 0-2. Participants must not be pregnant, use two forms of contraception if applicable, and cannot have had certain other treatments or conditions that would interfere with the study.

What is being tested?

The trial is testing the safety and effectiveness of combining bexarotene (a vitamin A-like drug) with TSEB radiotherapy—a type of radiation treatment for the skin—in treating MF. The goal is to see if using both treatments together works better than using them separately.

What are the potential side effects?

Potential side effects include those commonly associated with radiation therapy such as skin irritation or redness. Bexarotene may cause issues like headaches, rash, fatigue, nausea, blood lipid abnormalities and underactive thyroid.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of the day.

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My skin cancer is confirmed as mycosis fungoides by a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unwilling to use two forms of contraception during the study.

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I have been diagnosed with ALCL or another type of non-Hodgkin lymphoma.

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I do not have conditions like high blood fats that would make bexarotene unsafe for me.

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I have been diagnosed with another type of cancer besides skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of radiation dermatitis grade 3+

Secondary study objectives

Overall skin response rate

Side effects data

From 2014 Phase 4 trial • 59 Patients • NCT01007448

57%

Hypertriglyceridemia

40%

Hypothyroidism

23%

Headache

23%

Hypercholesterolemia

17%

Skin exfoliation

13%

Bacterial test positive

13%

Thyroxine free decreased

10%

Blood triglycerides increased

10%

Alanine aminotransferase increased

10%

Urinary tract infection

10%

Aspartate aminotransferase increased

10%

Neutrophil count decreased

Lethargy

White blood cell count decreased

Diarrhea

Arthralgia

Hypertension

Nasopharyngitis

Neutropenia

Hypercreatinaemia

Oedema peripheral

Osteoporosis

Proteinuria

Fatigue

Hypertriglyceridaemia

Sinusitis

Upper respiratory tract infection

Atrioventricular block first degree

Nausea

Renal failure

Cardiac failure congestive

Hydronephrosis

Peripheral vascular disorder

Muscle spasms

Syncope

Cholecystitis

Chest pain

Bone marrow failure

Lumbar vertebral fracture

100%

80%

60%

40%

20%

Study treatment Arm

Bexarotene 150 mg/m^2/Day

Bexarotene 300 mg/m^2/Day

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Bexarotene Combined With RadiotherapyExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bexarotene

2014

Completed Phase 4

~320

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bexarotene, a form of vitamin A, activates retinoid X receptors, which can halt the growth of cancer cells and induce their death. TSEB Radiotherapy uses low-dose radiation to target and kill cancer cells on the skin's surface without penetrating deeper tissues. These mechanisms are crucial for CTCL patients as they offer targeted treatments that can effectively reduce tumor burden and manage symptoms with potentially fewer systemic side effects compared to more invasive therapies.