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

Primary Purpose

Pediatric Malignant Brain Tumor -Diffuse Intrinsic Pontine Glioma

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Palliative re-irradiation for progressive DIPG in children
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Malignant Brain Tumor -Diffuse Intrinsic Pontine Glioma

Eligibility Criteria

1 Year - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

re-irradiation

Arm Description

re-irradiation for progressive DIPG in children

Outcomes

Primary Outcome Measures

delaying disease progression
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

improving symptoms
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.

Full Information

First Posted
January 13, 2013
Last Updated
April 19, 2015
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01777633
Brief Title
Palliative Re-irradiation for Progressive Diffuse Intrinsic Pontine Glioma (DIPG) in Children
Official Title
Palliative Re-irradiation for Progressive Diffuse Intrinsic Pontine Glioma (DIPG) in Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Malignant Brain Tumor -Diffuse Intrinsic Pontine Glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
re-irradiation
Arm Type
Experimental
Arm Description
re-irradiation for progressive DIPG in children
Intervention Type
Radiation
Intervention Name(s)
Palliative re-irradiation for progressive DIPG in children
Primary Outcome Measure Information:
Title
delaying disease progression
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
improving symptoms
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age:1 year-22 years Patient/parent consent 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) 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. 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: Radiation necrosis post first irradiation Unstable vital signs Less than X months since previous irradiation
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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