20 Participants Needed

Bexarotene + Radiotherapy for Cutaneous T-Cell Lymphoma

SN
NK
BI
SG
Overseen ByShamir Geller
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Do I need to stop my current medications to join the trial?

The trial does not specify that you must stop all current medications, but you cannot take oral retinoid therapy within 3 weeks of starting the study drug. Gemfibrozil is prohibited, and you should avoid strong/moderate CYP3A4 inducers and inhibitors if possible. Systemic steroids are not allowed within two weeks of the first dose, unless approved by the investigator.

Do I need to stop my current medications for this trial?

You may need to stop certain medications before joining the trial. Specifically, you cannot take oral retinoid therapy within 3 weeks of starting the study drug, and you should avoid gemfibrozil and certain other medications that interact with bexarotene. It's best to discuss your current medications with the study team to see if any changes are needed.

What safety data is available for Bexarotene treatment in cutaneous T-cell lymphoma?

Bexarotene, also known as Targretin, has been studied for its safety in treating cutaneous T-cell lymphoma. Adverse events associated with its use include bleeding, hemorrhage, coagulopathy, hypertriglyceridemia, central hypothyroidism, and xeroderma. These side effects can often be managed with dose adjustments or additional medications. Bexarotene is generally well-tolerated and has shown efficacy in clinical trials, with a response rate greater than 50% in patients who were refractory or intolerant to previous therapies. It is considered a good candidate for combination therapy due to its minimal bone marrow toxicity.12345

Is the combination of Bexarotene and Radiotherapy safe for treating Cutaneous T-Cell Lymphoma?

Bexarotene, used for treating Cutaneous T-Cell Lymphoma, can cause side effects like bleeding, high triglycerides (a type of fat in the blood), and thyroid issues. These side effects can often be managed with medication adjustments or additional treatments.12345

Is the drug Bexarotene a promising treatment for cutaneous T-cell lymphoma?

Yes, Bexarotene is a promising drug for treating cutaneous T-cell lymphoma. It has shown a good response rate in patients who did not respond to previous treatments. It is generally well-tolerated and can be used in combination with other therapies, making it a flexible option for treatment.12456

What makes the drug Bexarotene unique for treating cutaneous T-cell lymphoma?

Bexarotene is a unique drug for cutaneous T-cell lymphoma because it is a synthetic retinoid that specifically targets retinoid X receptors, offering a novel mechanism of action compared to other treatments. It is effective in patients who have not responded to previous therapies and can be used in combination with other treatments due to its low bone marrow toxicity.12456

What data supports the idea that Bexarotene + Radiotherapy for Cutaneous T-Cell Lymphoma is an effective treatment?

The available research shows that Bexarotene, when used alone, has been effective in treating Cutaneous T-Cell Lymphoma. In one study, 71% of patients who took Bexarotene capsules experienced a positive response, with improvements starting in about 27 days and lasting for an average of 92 days. Another study found that Bexarotene had a response rate of over 50% in patients who did not respond to other treatments. These results suggest that Bexarotene is effective on its own, and it is considered a good candidate for combination with other treatments like radiotherapy. However, the specific combination of Bexarotene and radiotherapy was not directly studied in the available research.12457

What data supports the effectiveness of the drug Bexarotene for treating cutaneous T-cell lymphoma?

Research shows that Bexarotene has been effective in treating cutaneous T-cell lymphoma, with more than 50% of patients responding positively, even those who did not respond to previous treatments. In one study, 71% of patients achieved a partial response, indicating that Bexarotene can be a beneficial option for this condition.12457

Who Is on the Research Team?

Brandon Imber, MD, MA - MSK Radiation ...

Brandon Imber, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Baseline mSWAT score of at least 10
My skin cancer is at least stage IB or I have Sézary syndrome, and I haven't had systemic treatments or they didn't work.
I am using stable doses of medications to manage itching.
See 3 more

Exclusion Criteria

Pregnancy
High likelihood of protocol non-compliance (in opinion of investigator)
I have been diagnosed with ALCL or another type of non-Hodgkin lymphoma.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bexarotene and TSEB radiotherapy. Bexarotene starts at 150 mg daily on Day 1, increasing to 300 mg daily on Day 15. TSEB starts on Day 22 with safety assessment on Day 52.

82 days
Multiple visits for treatment and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of radiation dermatitis and skin response.

1 month

What Are the Treatments Tested in This Trial?

Interventions

  • Bexarotene
  • Total Skin Electron Beam (TSEB)
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Bexarotene Combined With RadiotherapyExperimental Treatment2 Interventions

Bexarotene is already approved in United States, European Union for the following indications:

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Approved in United States as Targretin for:
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Approved in European Union as Targretin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Published Research Related to This Trial

Bexarotene, an antitumoral agent for cutaneous T-cell lymphoma, has been shown to increase clotting times in both in vitro and in vivo studies, indicating its anticoagulant effects.
The drug primarily inhibits factor IX and factor X without significantly affecting other coagulation factors, suggesting that patients on bexarotene should be monitored for coagulation issues, especially if they have existing deficiencies.
Interactions of bexarotene (LGD1069, Targretin) with the coagulation system.Hespel, A., Mejdoubi-Charef, N., Yous, S., et al.[2018]
In a study involving eight patients with cutaneous T-cell lymphoma, bexarotene showed significant efficacy, with 71% of those taking the oral formulation achieving a partial response within an average of 27 days.
Bexarotene was generally well-tolerated, although the oral form caused hypertriglyceridemia in some patients; the topical gel showed long-lasting effects, with one patient maintaining a partial response for 31 months.
Bexarotene capsules and gel for previously treated patients with cutaneous T-cell lymphoma: results of the Australian patients treated on phase II trials.Prince, HM., McCormack, C., Ryan, G., et al.[2019]
In a phase III study involving 50 patients with early-stage cutaneous T-cell lymphoma, topical bexarotene gel 1% showed substantial efficacy, with overall response rates of 44% to 54% depending on the assessment method used.
The treatment was generally well tolerated, with only mild to moderate side effects such as skin irritation and pruritus, and no serious treatment-related adverse events reported.
Topical bexarotene therapy for patients with refractory or persistent early-stage cutaneous T-cell lymphoma: results of the phase III clinical trial.Heald, P., Mehlmauer, M., Martin, AG., et al.[2019]

Citations

Interactions of bexarotene (LGD1069, Targretin) with the coagulation system. [2018]
Bexarotene capsules and gel for previously treated patients with cutaneous T-cell lymphoma: results of the Australian patients treated on phase II trials. [2019]
Topical bexarotene therapy for patients with refractory or persistent early-stage cutaneous T-cell lymphoma: results of the phase III clinical trial. [2019]
Bexarotene: a clinical review. [2018]
Bexarotene therapy for mycosis fungoides and Sézary syndrome. [2018]
Rexinoid bexarotene modulates triglyceride but not cholesterol metabolism via gene-specific permissivity of the RXR/LXR heterodimer in the liver. [2021]
Bexarotene--an alternative therapy for progressive cutaneous T-cell lymphoma? First experiences. [2019]
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