Clinical Trial to Assess the Safety and Efficacy of AloCELYVIR With Newly Diagnosed Diffuse Intri… (NCT04758533) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
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
Spain13 participantsStarted 2021-04-19
Plain-language summary
The aim of this study is to assess the safety and efficacy of AloCELYVIR, which consist in bone marrow-derived allogenic mesenchymal stem cells infected with an oncolytic Adenovirus, ICOVIR-5. It has recently been proven that this type of cells are able of transporting oncolytic substances to tumor targets that are difficult to reach, such as medulloblastomas and gliomas, youth cancers located in the cranial cavity that have a poor prognosis and a fatal outcome. In addition, to exerting an anti-tumor action, this virus has the ability to stimulate the immune response, making the therapy even more effective. Thus, the diffuse intrinsic pontine glioma and the medulloblastoma in relapse/progression have been chosen to study the potential of this new advanced therapy through a weekly infusion for 8 weeks.
Who can participate
Age range1 Year – 21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients aged 1 to 21 years.
✓. Written informed consent signed by the patients legal representative and, if applicable, the minor (informed consent in patients 12 years of age or older).
✓. Measurable or evaluable disease according to RANO criteria.
✓. Appropriate functional status, organic function (renal, hepatic) and hematological values:
✓. Patient able to comply with treatment and schedule of visits and assessments
✓. Life expectancy of ≥8 weeks.
✓. Appropriate contraceptive methods for sexually active males and females of childbearing age
✓. Negative pregnancy test in blood or urine for females of childbearing age
Exclusion criteria
✕. Previous treatment with CELYVIR or AloCELYVIR.
✕. Known active bacterial, viral, fungal or parasitic infection not controlled
✕. Known active Hepatitis B or C virus or VIH infection.
✕. If patients are treated with corticosteroids, they should be clinically stable and on stable or tapering doses of steroids for at least one week.
✕. To be receiving another anti-cancer treatment not foreseen in this protocol or to anticipate receiving it during the patient's participation in the same concomitant with the experimental treatment.
✕. Clinically significant or uncontrolled serious active and past systemic diseases that may pose an added risk to the patient
✕. Spontaneous massive intratumoral bleeding. Patients with postoperative bleeding (in case of biopsy or surgery) may be included in the study provided that the bleeding is controlled. The same rule applies for other postoperative complications (infection, loss of cerebrospinal fluid, absence of wound closure, subdural collection ...)
✕. Patients who have previously received radiotherapy to the brain stem for another malignancy