Hypofractionated Radiotherapy for Recurrent DIPG

Study Purpose

This study evaluates the feasibility of hypofractionated radiotherapy (RT) in the palliative treatment of recurrent diffuse intrinsic pontine glioma (DIPG). Participants will receive 15 Gy in 3 fractions as opposed to the standard 20 Gy in 10 fractions.

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	N/A - 30 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients must be ≤30 years of age. 2. Patients must have a diagnosis of progressive DIPG. 3. Received prior IMRT based definitive radiotherapy to a dose of ≥54 Gy. 4. The patient and or parent/legal guardian must be physically and mentally capable of signing the consent form of their own volition. 5. Steroids dosage must be unchanged for 5 days. 6. No Bevacizumab within 21 days (Half-life 11 days ~)

Exclusion Criteria:

1. Patients with incomplete medical records. 2. Patients with prior history of reirradiation for DIPG. 3. Life expectancy < or equal to 1 month. 4. Pregnant women. 5. Age >30. 6. Prisoners. 7. Concurrent systemic therapy at the time of reirradiation. 8. Physically or mentally incapable of signing the consent form of their own volition. 9. < 6 mos time interval between completion of initial RT to start of reRT.

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.	NCT03841435
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.	University of Cincinnati
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Luke E Pater, MD
Principal Investigator Affiliation	University of Cincinnati
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Completed
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Recurrent Diffuse Intrinsic Pontine Glioma

Arms & Interventions

Arms

Experimental: Hypofractionated Radiotherapy

15 Gy given in 3 fractions over 2 weeks

Interventions

Radiation: - Hypofractionated Radiotherapy

Radiotherapy Treatment, totaling 15 Gy, will be given in 3 fractions over 2 weeks.

Contact a Trial Team

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University of Cincinnati, Cincinnati, Ohio

Status

Address

University of Cincinnati

Cincinnati, Ohio, 45267

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