Clinical Trial to Assess the Safety and Efficacy of AloCELYVIR With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) in Combination With Radiotherapy or Medulloblastoma in Monotherapy

Inclusion Criteria

• •1. Patients aged 1 to 21 years.
• •2. Written informed consent signed by the patients legal representative and, if applicable, the minor (informed consent in patients 12 years of age or older).
• •3. Measurable or evaluable disease according to RANO criteria.
• •4. Appropriate functional status, organic function (renal, hepatic) and hematological values:
• •* Lanksy and karnofsky functional status ≥50%. Patients who use a wheelchair due of tumor-associated paralysis will be considered as outpatients for functional status evaluation.
• •* Haematology function:
• •* Platelet count ≥75.000/µL (without support for 3 days)
• •* Absolute neutrophil count (ANC) ≥500/ µL (without growth factor for 3 days)
• •* Hemoglobin ≥ 8 g/dL (Transfusion allowed)
• •* Liver and renal function
• •* Glomerular filtration rate (GFR) (estimated by Schwartz ) \>60 mL/min/1.73 m2
• •* Total bilirubin ≤ 1.5 × the upper limit of normal (ULN)
• •* Transaminases (GOT and GPT) ≤3 × the upper limit of normal (ULN). ≤ 5 times ULN for patients with hepatic metastasis.
• •5. Patient able to comply with treatment and schedule of visits and assessments
• •6. Life expectancy of ≥8 weeks.
• •7. Appropriate contraceptive methods for sexually active males and females of childbearing age
• •8. Negative pregnancy test in blood or urine for females of childbearing age
• •1. Patient with new DIPG diagnosis (clinical, radiological, or histological in case a biopsy was performed before being included in the study).
• •2. Not having received previous treatment with radiotherapy or chemotherapy.
• •3. Patient able to receive radiotherapy
• •1. Patient diagnosed with relapsed and/or refractory medulloblastoma. Patients must have received at least surgery, radiation therapy and chemotherapy as part of standard treatment and have failed these treatments before they can participate in this study.
• •2. To be recovered to ≤ G1 from the toxic effects according to CTCAE derived from the previous treatments, excluding ototoxicity, alopecia and peripheral neurotoxicity.