Oncolytic Adenovirus, DNX-2401, for Naive Diffuse Intrinsic Pontine Gliomas

Inclusion Criteria:

1. Informed consent OF PATIENT OR PARENTS
2. Patient must be, in the investigator opinion, able to comply with all the protocolprocedures.
3. Age 1 - 18 years
4. Negative pregnant blood test in case of fertile women (A woman is considered ofchildbearing potential (WOCBP), i.e. fertile, following menarche and unlesspermanently sterile. Permanent sterilization methods include hysterectomy, bilateralsalpingectomy and bilateral oophorectomy.
5. Patient newly diagnosed of DIPG in MRI
6. Lansky Performance Status ≥ 70 before inclusion
7. Lesion considered by the investigator to be accessible for stereotactic biopsy. Lesionlocation will allow injection without entrance of virus in the ventricular system.
8. No previous treatment for DIPG

Exclusion Criteria:

1. Severe infections or intercurrent medical conditions including, but not limited to,severe renal, hepatic, heart or bone marrow failure, that, on investigator´s criteria,do not allow the inclusion. Patients must be afebrile at baseline [i.e., < 38 degrees (Cº)].
2. Investigational medication in the previous 30 days.
3. Subjects with immunodeficiency, autoimmune conditions or active hepatitis.
4. Any medical or psychological condition that might interfere with the subject's abilityto participate if older than 16 years or parents ability when younger than 16, or giveinformed consent or would compromise the patient's ability to tolerate therapy or anydisease that will obscure toxicity or dangerously alter drug metabolism.
5. Tumor with multiple locations or doubt in MRI of a DIPG.
6. Pregnant or breast-feeding females will be excluded, due to the risk for the fetaldevelopment of a recombinant virus containing genes related to cellular growth anddifferentiation.
7. Severe bone marrow hypoplasia.
8. AST (aspartate transaminase) and/or ALT (alanine transaminase)> 3 times over uppernormal laboratory level
9. Neutrophils < 1 x 109/L
10. Thrombocytes ≤ 100 x 109/L
11. Hemoglobin < 9g/dl
12. Patients with Li-Fraumeni Syndrome or with a known germ line deficit in theretinoblastoma gene or its related pathways.
13. Vaccinations of any kind within 30 days prior to DNX-2401 administration. 15.Transfusions or medications (G-CSF) to treat pancytopenia or other hematological conditionswithin 28 days of baseline.