Feasibility clinical trial of the combination of AloCelyvir with chemotherapy and radiotherapy for the treatment of children and adolescents with relapsed or refractory extracranial solid tumors.

Prior treatment

• Previous treatment with Celyvir.
• Active acute toxicities of previous treatment grade ≥3 of the CTCAE v4.
• Patients with CNS metastases should be clinically stable and with stable or decreasing doses of steroids for at least one week.

Other illness

• Known and uncontrolled bacterial, viral, fungal or parastaria active infection.
• Known active infection for hepatitis or HIV virus.
• Serious active and past systemic diseases that are clinically significant or uncontrolled, which may imply an added risk for the patient.
• Allergy to Penicillin or its derivatives.

• Patients aged between 1 year and ≤21 years.
• Informed consent in writing according to current legislation.
• Washing periods compared to previous treatments.
• Patients with extra-cranial solid tumor, relapsed or refractory, for which there is no standard curative treatment
• Disease measurable or evaluable according to RECIST criteria v1.1.
• Patients for whom the combination with the proposed chemotherapy and radiotherapy regimens is considered adequate. Patients may have previously received the same schemes.
• Adequate functional status, organic function (renal, hepatic) and hematological values.
• Patient capable of complying with the treatment and plan of visits and evaluations.
• Life expectancy ≥3 months.
• Appropriate contraceptive methods for sexually active men and women of childbearing age.
• Negative pregnancy test for women of childbearing age.