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Vertebral Body Sparing Craniospinal Irradiation for Pediatric Patients With Cancer of the Central Nervous System

Study Purpose

This trial studies the feasibility of using intensity modulated proton therapy to deliver craniospinal irradiation while avoiding the bones of the vertebral column. Intensity modulated proton therapy is an advanced radiation therapy modality that uses high energy protons to kill cancer cells and shrink tumors, and may reduce the side effects of treatment by reducing radiation exposure to the spinal column.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 3 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Pathologic diagnosis of central nervous system malignancy requiring craniospinal irradiation.
  • - Signed informed consent and assent when indicated.

Exclusion Criteria:

  • - Any contraindication to undergoing MRI (ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial cardiac valves or devices, electrical implants such as cardiac pacemakers or perfusion pumps).
Metal fragments, shrapnel, or tattoos near the eye.
  • - Any major uncontrolled or poorly controlled current illness that would limit compliance with study requirements.
  • - Pregnant females are excluded.
Females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04276194
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Emory University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bree R Eaton
Principal Investigator Affiliation Emory University Hospital/Winship Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Malignant Central Nervous System Neoplasm
Additional Details

PRIMARY OBJECTIVES:

  • I. To demonstrate the feasibility and safety of using intensity modulated proton therapy to deliver vertebral body sparing craniospinal irradiation in growing children.
Ia. To report the dose received to the vertebral bodies and the dose gradient/heterogeneity within the vertebral body. Ib. To document, using weekly cone beam computed tomography (CT) of the cervical and lumbar spine, delivered dose in comparison with planned dose after accounting for any errors in patient positioning.
  • II. To evaluate acute toxicity of vertebral body sparing (VBS) craniospinal irradiation (CSI).
IIa. To report absolute lymphocyte counts over time and occurrence of grade 3-4 hematological toxicity. IIb. To report the incidence and severity of any grade esophagitis during or within 4 weeks of radiation therapy.
  • III. To evaluate the feasibility of magnetic resonance imaging (MRI) imaging during CSI therapy as in vivo proton range verification.
IIIa. To demonstrate the feasibility of completing interim non-contrast MRIs of the spine during treatment. IIIb. To characterize the earliest time point at which radiation induced bone marrow changes can be detected in children receiving proton CSI. OUTLINE: Patients undergo intensity modulated proton therapy once daily over 30 fractions and also undergo MRI over 20 minutes during fractions 7, 13, 20, and 30 of radiation in the absence of disease progression or unacceptable toxicity. After the completion of study treatment, patients are followed up at 4 weeks and then every 3-12 months thereafter.

Arms & Interventions

Arms

Experimental: Treatment (intensity modulated proton therapy)

Patients undergo intensity modulated proton therapy once daily over 30 fractions and also undergo MRI over 20 minutes during fractions 7, 13, 20, and 30 of radiation in the absence of disease progression or unacceptable toxicity.

Interventions

Procedure: - Intensity-Modulated Proton Therapy

Undergo intensity modulated proton therapy

Procedure: - Magnetic Resonance Imaging

Undergo MRI

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Emory Proton Therapy Center, Atlanta, Georgia

Status

Address

Emory Proton Therapy Center

Atlanta, Georgia, 30308

Atlanta, Georgia

Status

Address

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322