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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month post-treatment

Awards & highlights

Study Summary

This trial is testing the safety of combining bexarotene with TSEB radiotherapy in people who have a common form of CTCL called mycosis fungoides.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of radiation dermatitis grade 3+

Secondary outcome measures

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%

Urinary tract infection

10%

Aspartate aminotransferase increased

10%

Alanine aminotransferase increased

10%

Blood triglycerides increased

10%

Neutrophil count decreased

Hypertension

Neutropenia

Arthralgia

Nasopharyngitis

Hypercreatinaemia

Oedema peripheral

Diarrhea

Lethargy

White blood cell count decreased

Osteoporosis

Proteinuria

Fatigue

Hypertriglyceridaemia

Sinusitis

Upper respiratory tract infection

Bone marrow failure

Muscle spasms

Nausea

Lumbar vertebral fracture

Hydronephrosis

Chest pain

Renal failure

Cardiac failure congestive

Syncope

Cholecystitis

Peripheral vascular disorder

Atrioventricular block first degree

100%

80%

60%

40%

20%

Study treatment Arm

Bexarotene 150 mg/m^2/Day

Bexarotene 300 mg/m^2/Day

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,790 Total Patients Enrolled

Sarah Noor, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Brandon Imber, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

6 Total Patients Enrolled

Media Library

Bexarotene (Retinoid X Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05296304 — Phase 1

Cutaneous T-Cell Lymphoma Research Study Groups: Bexarotene Combined With Radiotherapy

Cutaneous T-Cell Lymphoma Clinical Trial 2023: Bexarotene Highlights & Side Effects. Trial Name: NCT05296304 — Phase 1

Bexarotene (Retinoid X Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05296304 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Bexarotene earned the necessary certification from the FDA?

"Due to the early stage of research, Bexarotene was given an evaluation score of 1 for safety. This rating reflects a lack of assurance as there is limited data indicating its efficacy and security profile."

Answered by AI

How many subjects are currently participating in this clinical experiment?

"Affirmative. Data on clinicaltrials.gov indicates that this medical trial is still recruiting patients, which began back in March of 2022 and underwent a revision as recently as September 19th the same year. 20 volunteers are needed to be enrolled at one centre for study participation."

Answered by AI

Are there any vacancies for volunteers in this research program?

"Yes, the clinical trial is still actively recruiting participants. The initial posting of the study was on March 16th 2022 and has since been amended on September 19th. Currently, 20 people need to be recruited from a single site for this research project."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05296304.

All > Mycosis Fungoides