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.
Key facts
- Where
- Barcelona és Madrid, SpanyolországSee the 2 sites
- Phase
- 1. fázis
Where in Spanyolország
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
- Hospital Infantil Universitario Nino JesusMadrid, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus
- Trial code
- EU 2024-518417-25-00
- Record updated
- 2024. október 10.
- Original description
Dose confirmation phase: to evaluate the safety of the combination of AloCelyvir added to the cytoreductor scheme (combination of chemotherapy, surgery, radiotherapy).Read full original descriptionShow less
Dose confirmation phase: to evaluate the safety of the combination of AloCelyvir added to the cytoreductor scheme (combination of chemotherapy, surgery, radiotherapy).
Inclusion: 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.
Exclusion: 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; 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.