Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation

Study Purpose

This research study is studying proton radiation as a possible treatment for brain tumor that requires radiation. The radiation involved in this study is: -Proton Radiation

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:

- Age ≥ 3 years and ≤ 18 years at the time of registration.

- Histologically proven malignancy necessitating cranio-spinal irradiation.

This will include patients with a diagnosis of medulloblastoma, Supratentorial primitive neuroectodermal tumor (SPNET), germ cell tumor (GCT), disseminated ependymoma, embryonal tumor with abundant neuropil and true rosettes (ETANTR), Atypical Teratoid/Rhabdoid Tumor (ATRT), and disseminated low-grade glioma (LGG).

- Life expectancy ≥ 12 months.

- Signed informed consent document and assent when appropriate.

- HGB of > 10 g/L and PLT count > 80 K/uL.

Exclusion Criteria:

- Any prior therapeutic radiation therapy > 500 cGy has been delivered.

- Individuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 5 years and are deemed by the investigator to be a low-risk for recurrence of that malignancy; or, have had only cervical cancer in situ, or basal cell or squamous cell carcinoma of the skin.

- Any major uncontrolled or poorly controlled intercurrent 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.

- Patients that receive concurrent chemotherapy with the exception of concurrent Vincristine.

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.	NCT03281889
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.	Massachusetts General Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Shannon MacDonald, MD
Principal Investigator Affiliation	Massachusetts General Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumor

Additional Details

This research study is a Pilot Study to determine whether using proton therapy in participants that require craniospinal radiation (whole brain and spinal cord radiation therapy) with sparing of the bony spine will work. This is the first time investigators are examining bone sparing proton therapy in pediatric craniospinal radiation. The FDA (the U.S. Food and Drug Administration) has not approved proton radiation for this specific disease but it has been approved for other uses. In this research study, the investigators are studying proton radiation in participants that require craniospinal radiation. The standard of care for this procedure is photon radiation, which is very similar to proton radiation. The investigators believe that the precision of proton radiation may help to reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue

Arms & Interventions

Arms

Experimental: Proton Radiotherapy

Patients will be treated with Proton Beam once daily 5 days per week. Doses will be prescribed such that maximum possible coverage is achieved

Interventions

Radiation: - Proton Beam

precision radiation that reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue

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.

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02214

Site Contact

Shannon MacDonald, MD

[email protected]

617-643-7250

MD Anderson Cancer Center, Houston, Texas

Status