A Phase 1/2 interventional study of Palliative re-irradiation for progressive DIPG in children in Pediatric Malignant Brain Tumor -Diffuse Intrinsic Pontine Glioma, sponsored by Hadassah Medical Organization. Completed at 1 site in Israel. Open to participants aged 1 Year to 22 Years. Per ClinicalTrials.gov, last updated 2015-04-21.
Sponsored by Hadassah Medical Organization · Phase 1/2, Interventional, and Treatment
Although DIPG is not curable, re-irradiation with a modest total dose and short treatment time provides good palliation of symptoms, improves quality of life, delays disease progression and has minimal and manageable toxicity.
Treatment plan:
At progression, full radiological and clinical documentation necessary including a neurological exam by a neurologist will be done. Progressive patients will be referred to radiotherapy.
Radiation guidelines:
30.6 Gray (Gy) will be applied in 1.8 to 2Gy fractions in conformal radiation to tumor bed. Radiation will be done in standard accelerators and according to standard guidelines used in treatment for all brain tumor patients.
Hadassah Medical Organization is the lead sponsor of 674 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
re-irradiation for progressive DIPG in children
Radiation: Palliative re-irradiation for progressive DIPG in children
delaying disease progression
clinical progression: close follow up including biweekly neurological assessments to evaluate for clinical progression. any onset of a new neurological deficit or deterioration of an existing deficit will require follow up within one week. persistent deficit will be considered clinical progression. progression on imaging: MRI will be done every 3 months. tumor growth of \>25% will be considered disease progression
Time frame: 1 year
improving symptoms
parents will report daily ADL (Activities of Daily Living), brainstem functions including double vision, voice, swallowing functions and facial nerve palsy. parents will also report motor functions of the child in the biweekly visits.
Time frame: 1 year
The record gives a start of Feb 2013, a primary completion of Feb 2015 and a completion of Feb 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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