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Study Summary
No. 2011-0804:.......Brain......Anita Mahajan......Radiation Oncology
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Study Summary Title
Study Summary
Number:		2011-0804
Study Title:Phase I/II study of reirradiation of recurrent or progressive brainstem glioma
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Physician New Patient Referral
Name:Anita MahajanPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Radiation OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-2300
Contact us about clinical trials
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General Information
Disease Group:BrainSupported By:N/A
Phase of Study:Phase I/Phase IIReturn
Visit:
Treatment
Agents:		RadiationHome Care:
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Description/
Intervention:		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.
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Study Objectives / Outcomes
Primary
  • Establish a safe dose of reirradiation in patients with recurrent and/or progressive diffuse intrinsic pontine glioma (DIPG) at 1 month following reirradiation

Secondary
  • Determine the tolerability and toxicity of reirradiation
  • Assess quality of life changes with reirradiation
  • Measure tumor response by Magnetic resonance imaging (MRI) imaging at 1 month following reirradiation
  • Document neurological function changes with reirradiation
  • Estimate progression free survival (PFS) and overall survival (OS)
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:12/07/2011
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:30
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
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 atleast 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 <Grade 3)

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
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Links
Registration Number: NCT01469247
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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