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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is testing a new form of radiation therapy to see if it can help control mycosis fungoides, a type of skin cancer.
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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To establish the overall response rate (ORR)
Side effects data
From 2017 Phase 2 trial • 10 Patients • NCT0180759840%
Fatigue
30%
Neutropenia
20%
Anorexia
20%
Constipation
20%
Cough
20%
Abdominal Pain
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%
Intracranial hemorrhage
10%
Thrombocytopenia
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%
Hyperhidrosis
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%
0%
Study treatment Arm
Brentuximab Vedotin
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 2
~200
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,751 Total Patients Enrolled
10 Trials studying Mycosis Fungoides
419 Patients Enrolled for Mycosis Fungoides
Seagen Inc.Industry Sponsor
207 Previous Clinical Trials
69,127 Total Patients Enrolled
7 Trials studying Mycosis Fungoides
339 Patients Enrolled for Mycosis Fungoides
Bouthaina Dabaja, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
55 Total Patients Enrolled
1 Trials studying Mycosis Fungoides
4 Patients Enrolled for Mycosis Fungoides
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My kidney function is severely impaired.I do not have any serious illnesses that would affect my treatment.I am on a stable dose of steroids, and stopping them might cause harm.My blood has Sezary cells but less than 1000 cells/microlitre.My skin cancer tested positive for CD30.I am not using other cancer treatments for mycosis fungoides or Sezary syndrome.I am capable of only limited self-care, confined to a bed or chair more than 50% of waking hours.My skin cancer is confirmed as mycosis fungoides at stage I-IV.I stopped my cancer treatment at least a week ago.I have moderate to severe nerve pain or tingling.My liver function is moderately or severely impaired.I am HIV positive, on stable HIV treatment for 12 weeks, and my CD4 count is over 200.
Research Study Groups:
This trial has the following groups:- Group 1: Brentuximab vedotin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are under care in this clinical trial?
"That is accurate. The information available on clinicaltrials.gov points to this trial actively recruiting patients as of right now. This trial was first posted on October 13th, 2020 and was last updated yesterday. They are looking for 30 individuals total, across one site."
Answered by AI
Has Brentuximab vedotin received government approval for use?
"Brentuximab vedotin has only been studied in Phase 2 trials, so there is not enough evidence to support its efficacy. However, there is data suggesting that it is safe, so it received a score of 2."
Answered by AI
Is this research study actively recruiting participants?
"Yes. The clinical trial is still recruiting participants, as noted on clinicaltrials.gov. The site was last updated on 10/14/2022, and the trial is looking for 30 more participants from 1 site."
Answered by AI
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