Your session is about to expire
← Back to Search
Radiation Therapy
Electron Beam Therapy for Sclerodermatous GVHD
Phase < 1
Waitlist Available
Led By Karamjeet S Sandhu
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 168
Awards & highlights
Study Summary
This trial is testing whether a single small dose of electron beam radiotherapy can help to treat patients with sclerodermatous chronic graft versus host disease that has not responded to other treatments.
Who is the study for?
Adults with stubborn sclerodermatous chronic GVHD, who've tried at least two other treatments without success, can join this trial. They must be able to have clinical photos taken and agree to use birth control. Pregnant or breastfeeding women, recent recipients of cancer therapies, or those with certain genetic mutations cannot participate.Check my eligibility
What is being tested?
The trial is testing a single dose of electron beam radiotherapy (e-BRT) at 10 Gy for patients with refractory sclerodermatous chronic GVHD after bone marrow transplants. It aims to see if e-BRT can turn active skin cells into inactive ones faster and increase immune cells that help control the disease.See study design
What are the potential side effects?
Potential side effects include skin reactions similar to sunburn, fatigue, hair loss in the treated area, and possible changes in skin color. There may also be risks associated with biopsies such as bleeding or infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 168
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 168
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of toxicity
Secondary outcome measures
Incidence of disease specific response
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (electron beam radiotherapy)Experimental Treatment7 Interventions
Patients undergo radiotherapy simulation on day -14 using either a clinical setup or CT simulation at the discretion of the treating radiation oncologist. Patients then undergo electron beam radiotherapy on day 0. Patients also undergo skin biopsies at baseline, day 28, and day 168 after radiotherapy, and high frequency ultrasound (HFUS) scans on days 28, 56, 84, 112, 140, and 168 after radiotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Radiation Therapy Treatment Planning and Simulation
2014
N/A
~10
Skin Biopsy
2015
Completed Phase 4
~680
Biospecimen Collection
2004
Completed Phase 2
~1730
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,446 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,473 Total Patients Enrolled
Karamjeet S SandhuPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
63 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are 18 years or older.You have specific gene mutations in TP53, NBS, or ATM.Use of herbal medications.You have tried and not responded to at least two different treatments for sclerodermatous chronic GvHD.You have been diagnosed with a specific type of graft-versus-host disease called sclerodermatous GVHD.Women who could become pregnant must have a negative pregnancy test before starting the study treatment. If the urine test shows a possible pregnancy or the result is unclear, a blood test will be needed to check for pregnancy. This test should be done within 7 days before starting the treatment, unless the study says otherwise.You have sclerodermatous chronic graft-versus-host disease that has come back or has not responded to previous treatment.You have a tumor that is at least 2.0 cm in size that can be measured.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (electron beam radiotherapy)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any available slots left for prospective participants in this trial?
"According to the clinicaltrials.gov, this research is no longer recruiting participants as it was last updated on November 22nd 2022. Nevertheless, patients can still find 2566 other active studies that are currently enrolling volunteers."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger