Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradicatio
- Conditions
- Diffuse Intrinsic Pontine Glioma and Diffuse midline glioma, K27M mutantMedDRA version: 20.0Level: PTClassification code 10006143Term: Brain stem gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-001929-32-NL
- Lead Sponsor
- Gustave Roussy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 315
*Diagnosis of DIPG (clinical and radiological, or histological in case the
biopsy was performed before study entry)
*Non-brainstem diffuse midline gliomas, H3K27M mutant (NB-DMG), will
be eligible for the trial after biopsy or surgery.
*DIPG or NB-DMG at diagnosis: no prior chemotherapy for the present
cancer; no prior cerebral radiation therapy
*NB : Metastatic disease allowed. Patient with metastatic disease are
eligible for the study (if diagnosis of DIPG /NB-DMG confirmed). In this
situation, radiotherapy will have to start within three weeks after the
biopsy while targerted treatment will start at the end of the irradiation.
*Age > 6 months and < 30 years. For children below the age of 3 years,
inclusion in the study and medical decisions should be discussed with
the coordinating investigator.
*Eligible for a biopsy, or biopsy performed for diagnostic purpose and
material available for the biomarker assessment
*Eligible for cerebral radiotherapy
*Patient covered by an health insurance if national requirement
*Written informed consent given by patient and/or parents/legal
representative for biomarkers assessment and registration in the study.
*Eligibility criteria for the study (see above)
*Confirmed histological diagnosis of diffuse intrinsic pontine glioma
(grade II, III, IV WHO), or NB-DMG confirmed by central pathology
review .
*Life expectancy > 12 weeks after the start of study treatment
*Karnofsky performance status scale or Lansky Play Scale > 50%.
*Absolute neutrophil count > 1.5 x 109/l, Platelets > 100 x 109/l
*Total bilirubin < 1,5 x ULN, AST and ALT< 2,5 x ULN
*Serum creatinine < 1,5 X ULN for age. If serum creatinine > 1,5 ULN,
creatinine clearance must be > 70 ml/min/1,73 m² (EDTA radioisotope
GFR or 24 hours urines collection)
*Normal coagulation tests within the local reference ranges
*No current organ toxicity > grade 2 according to the NCI-CTCAE version
4.0 especially cardiovascular, pulmonary or renal disease (, including but
not limited to: congenital long QT syndrome, nephrotic syndrome,
glomerulopathy, uncontrolled high blood pressure despite adequate
treatment, interstitial lung disease, pulmonary arterial hypertension).
*Effective and appropriate contraception for patients (male and female)
of reproductive potential during their entire participation in the study
and during 6 months after the end of treatment
*Negative pregnancy test evaluated in the last week in sexually active
females of reproductive potential
*Written informed consent given by the patient / legal representative
for treatment
Are the trial subjects under 18? yes
Number of subjects for this age range: 315
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
*Spontaneous massive intratumour bleeding. Patients with postoperative bleeding will be allowed to enter the study provided the hemmorhage is controled. Same rule applies for the other post-operative complications (infection, CSF leakage, absence of wound closure, subdural collection…).
*Any other concomitant anti-cancer treatment not foreseen by this protocol
*Any other cancer during the last 5 years
*Uncontrolled intercurrent illness or active infection
*Any other co-morbid condition that in the investigator's opinion would impair study participation
*Unable for medical follow-up (geographic, social or mental reasons)
*Patient not fulfilling one of the previous eligibility criteria.
*Patient previously treated with irradiation on the brainstem for another neoplasm
*Patient with congenital galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
*Patient not covered by a social security agreement accepted in the treating country if national requirement
*Pregnant or breast feeding women
*PTEN-positivity (evaluated by IHC)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method