Status:
COMPLETED
Diffuse Intrinsic Pontine Glioma (DIPG) Reirradiation (ReRT)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain Cancer
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical research study is to find a safe dose of radiation that can be given to patients with brainstem glioma who have already received radiation therapy. You will receive photon r...
Detailed Description
Radiation Therapy Administration: If you are found to be eligible to take part in this study, you will be assigned to a dose level of radiation therapy based on when you join this study. Three (3) do...
Eligibility Criteria
Inclusion
- 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
- Radiation therapy to brain for DIPG that was completed at least 10 months prior to planned reirradiation
- 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.
- Signed informed consent by patient and/or parents or legal guardian
- Lansky/Karnofsky Performance Status score of 40-100
- Central nervous system function defined as not severely somnolent or comatose (central cortical neurotoxicity scale \<Grade 3)
- Life expectancy of \>/= 8 weeks
Exclusion
- Prior radiation of greater than 60 Gy to \>20% of brainstem.
- Patients with Neurofibromatosis 1 because the biologic behavior of their tumors may be more benign
- Asymptomatic patients because the primary goal of treatment is palliation of symptoms
- Pregnancy
Key Trial Info
Start Date :
December 7 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01469247
Start Date
December 7 2011
End Date
September 20 2022
Last Update
October 20 2022
Active Locations (2)
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1
Orlando Health
Orlando, Florida, United States, 32806
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030