Pediatric Malignant Brain Tumor -Diffuse Intrinsic Pontine Glioma Clinical Trial
Official title:
Palliative Re-irradiation for Progressive Diffuse Intrinsic Pontine Glioma (DIPG) in Children
| Verified date | December 2012 |
| Source | Hadassah Medical Organization |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | February 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year to 22 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hadassah Medical Organization | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
1 year | Yes |
| Secondary | 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. | 1 year | Yes |