Electron Beam Radiotherapy for the Treatment of Refractory Sclerodermatous Chronic Graft Versus Host Disease
NCT ID: NCT05515692
Last Updated: 2024-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2024-06-30
2024-09-18
Brief Summary
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Detailed Description
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I. To establish safety of 10 Gy of 6 MeV electron beam radiotherapy (e-BRT) administration in subjects with refractory sclerodermatous chronic graft-versus-host disease (cGVHD).
SECONDARY OBJECTIVE:
I. To provide preliminary efficacy data on the anti-fibrotic effects of e-BRT treatment at 4 and 24 weeks.
EXPLORATORY OBJECTIVES:
I. To evaluate the skin microenvironment 21 days before (baseline) and 28, and 168 days after e-BRT administration by assessing the presence and percentage of immune cell subsets (including but not limited to Th17 and Treg cells), presence of fibroblast and fibrocytes, and changes in the vasculature as measured by microvessel density (MVD) by CD31 and VEGF staining in tissue microarrays (TMA).
II. To assess changes in the presence and levels of GVHD inflammatory biomarkers and cytokines (including but not limited to IL-17A, IL-21, and IL-2) in patients' plasma after treatment with e-BRT.
OUTLINE:
Patients undergo radiotherapy simulation on day -14 using either a clinical setup or computed tomography (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.
After completion of the study, patients are followed up yearly.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (electron beam radiotherapy)
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.
Biospecimen Collection
Correlative studies
Computed Tomography
Undergo radiotherapy simulation using CT
Electron Beam Therapy
Undergo electron beam radiotherapy
High Frequency Ultrasound Imaging
Undergo HFUS
Questionnaire Administration
Ancillary studies
Radiation Therapy Treatment Planning and Simulation
Undergo radiotherapy simulation using clinical setup
Skin Biopsy
Undergo biopsy
Interventions
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Biospecimen Collection
Correlative studies
Computed Tomography
Undergo radiotherapy simulation using CT
Electron Beam Therapy
Undergo electron beam radiotherapy
High Frequency Ultrasound Imaging
Undergo HFUS
Questionnaire Administration
Ancillary studies
Radiation Therapy Treatment Planning and Simulation
Undergo radiotherapy simulation using clinical setup
Skin Biopsy
Undergo biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Agreement to allow the use of archival tissue from diagnostic tumor biopsies
* If unavailable, exceptions may be granted with study principal investigator (PI) approval
* Permitting to perform clinical photography
* Age: \>= 18 years
* Histologically confirmed sclerodermatous GHVD
* Relapsed/refractory sclerodermatous cGVHD
* Measurable disease of at least 2.0 cm
* Failed at least \>= 2 prior frontline therapies for sclerodermatous chronic GvHD
* Fully recovered from the acute toxic effects (except alopecia) to =\< Grade 1 to prior therapy
* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* To be performed within 7 days prior to Day 1 of protocol therapy unless otherwise stated
* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 month after the last dose of protocol therapy
* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
Exclusion Criteria
* Herbal medications
* Females only: Pregnant or breastfeeding
* Inability to comprehend and sign inform consent
* Individuals known to carry germline gene mutations in TP53, NBS and ATM.
* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Karamjeet S Sandhu
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Other Identifiers
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NCI-2022-05914
Identifier Type: REGISTRY
Identifier Source: secondary_id
21382
Identifier Type: OTHER
Identifier Source: secondary_id
21382
Identifier Type: -
Identifier Source: org_study_id
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