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Palliative Re-irradiation for Progressive Diffuse Intrinsic Pontine Glioma (DIPG) in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01777633
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : April 21, 2015
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Pediatric Malignant Brain Tumor -Diffuse Intrinsic Pontine Glioma Radiation: Palliative re-irradiation for progressive DIPG in children Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Palliative Re-irradiation for Progressive Diffuse Intrinsic Pontine Glioma (DIPG) in Children
Study Start Date : February 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: re-irradiation
re-irradiation for progressive DIPG in children
Radiation: Palliative re-irradiation for progressive DIPG in children

Primary Outcome Measures :
  1. delaying disease progression [ Time Frame: 1 year ]

    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

Secondary Outcome Measures :
  1. improving symptoms [ Time Frame: 1 year ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age:1 year-22 years
  2. Patient/parent consent
  3. Diagnosis of DIPG based on short classic history, clinical signs (long tract signs, cranial nerve deficits and ataxia) and classic MRI features (more than 2/3 of the tumor is located within the pons and tumor encompasses more than 60% of the pons)
  4. A patient will be eligible for reirradiation if progression is diagnosed following a period of at least 4 months of stable disease after first irradiation.
  5. Progression may be either clinical (new neurological deficit or worsening of an old deficit in two separate physical examinations) or radiological (tumor growth of >25%)

Exclusion Criteria:

  1. Radiation necrosis post first irradiation
  2. Unstable vital signs
  3. Less than X months since previous irradiation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01777633

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Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization

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Responsible Party: Hadassah Medical Organization Identifier: NCT01777633     History of Changes
Other Study ID Numbers: 027812-HMO-CTIL
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: December 2012
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases