Know Cancer

or
forgot password

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


Phase 1/Phase 2
1 Year
22 Years
Not Enrolling
Both
Pediatric Malignant Brain Tumor -Diffuse Intrinsic Pontine Glioma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

delaying disease progression

Outcome 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

Outcome Time Frame:

1 year

Safety Issue:

Yes

Authority:

Israel: Ministry of Health

Study ID:

027812-HMO-CTIL

NCT ID:

NCT01777633

Start Date:

February 2013

Completion Date:

February 2020

Related Keywords:

  • Pediatric Malignant Brain Tumor -Diffuse Intrinsic Pontine Glioma
  • Brain Neoplasms
  • Glioma
  • Pontine Glioma

Name

Location