CompletedPhase 1/2

Diffuse Intrinsic Pontine Glioma (DIPG) Reirradiation (ReRT)

United States12 participantsStarted 2011-12-07

Plain-language 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 radiation therapy. This type of radiation is similar to the radiation you have already had. Conformal radiotherapy or intensity modulated radiotherapy (IMRT) will be used to try to treat the tumor while affecting as little of the surrounding normal tissue as possible.

Who can participate

Age range17 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Optimal Dose Level Among Three Radiation Therapy (RT) Dose Levels

Timeframe: 1 month after radiation therapy

Trial details

NCT IDNCT01469247

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-20

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