What is the mechanism of action of this treatment?

Ultra-Low-Dose Total Skin Electron Beam Therapy (ULD-TSEBT) works by delivering targeted radiation to the skin, which helps to destroy cancerous cells while minimizing damage to surrounding healthy tissue. Brentuximab Vedotin is an antibody-drug conjugate that targets CD30-positive cells, delivering a cytotoxic agent directly to the cancer cells, leading to their destruction. These treatments are significant for Mycosis Fungoides patients because they offer targeted approaches that can effectively reduce tumor burden and manage symptoms with potentially fewer side effects compared to more generalized treatments. This targeted approach is crucial in managing a disease that primarily affects the skin and can significantly impact the patient's quality of life.

What side effects are associated with this type of intervention?

Ultra-Low-Dose Total Skin Electron Beam Therapy (ULD-TSEBT) commonly causes skin-related side effects such as erythema, dryness, itching, and peeling, with more severe but less common effects including blistering and secondary infections. Brentuximab Vedotin can cause peripheral neuropathy, fatigue, nausea, diarrhea, fever, and neutropenia, with severe side effects potentially including serious infections and infusion-related reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for Mycosis Fungoides, a type of cutaneous T-cell lymphoma. Brentuximab Vedotin, an antibody-drug conjugate targeting CD30-positive cells, is one such treatment. It has shown efficacy in patients with CD30-expressing cutaneous T-cell lymphomas, including Mycosis Fungoides. Additionally, localized radiation therapies, such as Total Skin Electron Beam Therapy (TSEBT), have been used to manage skin lesions in Mycosis Fungoides. These treatments aim to control symptoms and improve quality of life in affected patients.

What other types of research exist?

Promising novel alternatives for Mycosis Fungoides treatment in 2024 include: 1) Mogamulizumab, a monoclonal antibody targeting CCR4, which has shown efficacy in clinical trials for cutaneous T-cell lymphoma. 2) Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, which has demonstrated potential in treating relapsed or refractory Mycosis Fungoides. 3) Localized radiation options such as Total Skin Electron Beam Therapy (TSEBT) at higher doses or fractionated schedules, which may offer improved outcomes for some patients.

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Monoclonal Antibodies

Total-Skin Electron Beam Therapy + Brentuximab for Skin Cancer

Phase 2

Recruiting

Led By Bouthaina Dabaja, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

18 years of age or older

ECOG performance status score of ≤ 3

Must not have

Severe renal impairment (CrCL <30 mL/min)

Underlying medical conditions including unstable cardiac disease or other serious illness that would impair treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of low-dose skin radiation and a targeted cancer drug. It focuses on patients with a specific type of skin lymphoma that is hard to treat. The treatment works by using radiation to reduce cancer cells on the skin and a drug to kill them directly.

Who is the study for?

This trial is for adults with relapsed/refractory mycosis fungoides, a type of skin lymphoma. Participants must have at least 1% CD30 expression in their cancer cells and be stable on certain medications if needed. HIV+ patients can join if treated and with a CD4 count >200. People are excluded if they have severe kidney or liver issues, another primary malignancy treatment, grade 2+ neuropathy, or women not using birth control.

What is being tested?

The study tests ultra-low-dose total-skin electron beam therapy (ULD-TSEBT) combined with brentuximab vedotin to see its effectiveness against mycosis fungoides over a year. There's no wait time after previous cancer treatments before starting this trial.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as infusion reactions from brentuximab vedotin, nerve damage (neuropathy), fatigue, skin irritation from radiation therapy, and increased risk of infections.

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 am capable of only limited self-care, confined to a bed or chair more than 50% of waking hours.

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My skin cancer is confirmed as mycosis fungoides at stage I-IV.

Exclusion Criteria

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

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My kidney function is severely impaired.

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I do not have any serious illnesses that would affect my treatment.

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I am not using other cancer treatments for mycosis fungoides or Sezary syndrome.

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I have moderate to severe nerve pain or tingling.

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My liver function is moderately or severely impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2017 Phase 2 trial • 10 Patients • NCT01807598

40%

Fatigue

30%

Neutropenia

20%

Constipation

20%

Abdominal Pain

20%

Cough

20%

Anorexia

20%

Anemia

20%

Depression

20%

Diarrhea

20%

Dyspnea

20%

Infusion Related Reaction

20%

Rash

20%

Vomiting

10%

Respiratory, thoracic and mediastinal disorders - Other, Epiglottitis

10%

Thrombocytopenia

10%

Hyperhidrosis

10%

Intracranial hemorrhage

10%

Sinusitis

10%

Oral pain

10%

Edema limbs

10%

Portal vein thrombosis

10%

Pleural effusion

10%

Fever

10%

Nausea

10%

Alopecia

10%

Dry skin

10%

Pruritus

10%

Upper respiratory infection

10%

Vaginal infection

10%

Sore throat

10%

Hypoalbuminemia

10%

Ascites

10%

Dysphagia

10%

Wound infection

10%

Postnasal drip

10%

Dehydration

10%

Insomnia

10%

Ear pain

10%

Watering eyes

10%

Pain in extremity

10%

Urinary frequency

100%

80%

60%

40%

20%

Study treatment Arm

Brentuximab Vedotin

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: Brentuximab vedotinExperimental Treatment1 Intervention

Participant will receive radiation therapy to the entire skin surface over the course of 2 days. Each dose will take about 60 to 90 minutes and will vary from one patient to another

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brentuximab vedotin

2012

Completed Phase 4

~210

0 / 8Eligibility 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

Ultra-Low-Dose Total Skin Electron Beam Therapy (ULD-TSEBT) works by delivering targeted radiation to the skin, which helps to destroy cancerous cells while minimizing damage to surrounding healthy tissue. Brentuximab Vedotin is an antibody-drug conjugate that targets CD30-positive cells, delivering a cytotoxic agent directly to the cancer cells, leading to their destruction. These treatments are significant for Mycosis Fungoides patients because they offer targeted approaches that can effectively reduce tumor burden and manage symptoms with potentially fewer side effects compared to more generalized treatments. This targeted approach is crucial in managing a disease that primarily affects the skin and can significantly impact the patient's quality of life.