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

This study is not yet open for participant recruitment.
Verified December 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01777633
First received: January 13, 2013
Last updated: February 18, 2013
Last verified: December 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Palliative Re-irradiation for Progressive Diffuse Intrinsic Pontine Glioma (DIPG) in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • delaying disease progression [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 15
Study Start Date: February 2013
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: re-irradiation
re-irradiation for progressive DIPG in children
 Radiation: Palliative re-irradiation for progressive DIPG in children

  Eligibility

Ages Eligible for Study:   1 Year to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777633

Contacts
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Contact: Hadas Lemberg, PhD     00 972 2 6777572     lhadas@hadassah.org.il    
Principal Investigator: Iris Freid, M.D.            
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01777633     History of Changes
Other Study ID Numbers: 027812-HMO-CTIL
Study First Received: January 13, 2013
Last Updated: February 18, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Brain Neoplasms
Glioma
Pontine Glioma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Astrocytoma

ClinicalTrials.gov processed this record on May 23, 2013