Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01469247 : Diffuse Intrinsic Pontine Glioma (DIPG) Reirradiation (ReRT)
PhasePhase 1/Phase 2
AgesMin: N/A Max: 17 Years
Eligibility
Inclusion Criteria:

1. Diagnosis of DIPG by MRI imaging defined as tumor that has a pontine epicenter and is
diffuse (tumor that involves the majority (>50%) of the brainstem) on T2 or FLAIR
imaging rather than focal. Histologic confirmation is not required

2. Radiation therapy to brain for DIPG that was completed at least 10 months prior to
planned reirradiation

3. Clinical progression of symptoms with any radiographic progression on MRI within 21
days prior to registration (any progression in size or enhancement on MRI along with
worsening symptoms, will be defined as progression prior to enrollment). Radiographic
progression is defined as any increase in tumor size (in axial or sagittal images) or
progressive contrast enhancement and abnormal T2/FLAIR signal by MRI.

4. Signed informed consent by patient and/or parents or legal guardian

5. Lansky/Karnofsky Performance Status score of 40-100

6. Central nervous system function defined as not severely somnolent or comatose
(central cortical neurotoxicity scale
7. Life expectancy of >/= 8 weeks

Exclusion Criteria:

1. Prior radiation of greater than 60 Gy to >20% of brainstem.

2. Patients with Neurofibromatosis 1 because the biologic behavior of their tumors may
be more benign

3. Asymptomatic patients because the primary goal of treatment is palliation of symptoms

4. Pregnancy
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01469247      |      Link to official Clinicaltrials.gov listing
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