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

April 19, 2015 updated by: Hadassah Medical Organization

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 22 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: re-irradiation
re-irradiation for progressive DIPG in children
Radiation: Palliative re-irradiation for progressive DIPG in children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

January 13, 2013

First Submitted That Met QC Criteria

January 24, 2013

First Posted (ESTIMATE)

January 29, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 19, 2015

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 027812-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe