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

NCT04758533 | Active Not Recruiting Phase 1

• 3 other identifiers: FIBHNJ-2020-012020-004838-372022-502516-37-00
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diffuse Intrinsic Pontine Glioma; Medulloblastoma, Childhood, Recurrent

Keywords

Icovir-5; Mesenchymal stem cells; Medulloblastoma; Diffuse Intrinsic Pontine Glioma

Outcome Measures

Primary Outcomes (1)

• Dose-Limiting Toxicities rate (DLTs)

  Proportion of patients who has experienced a DLT

  1 Month

Secondary Outcomes (8)

• Objective response rate

  24 Months

• Feasibility of the combination/monotherapy

  1 Month

• Incidence of treatment-Emergent Adverse Event

  2,5 Months

• Progression-free survival (PFS)

  24 Months

• Overall Survival (OS)

  24 Months

Study Arms (1)

AloCELYVIR

EXPERIMENTAL

Patients will received weekly infusion of AloCELYVIR during 8 weeks.

Biological: AloCELYVIR

Interventions

AloCELYVIR BIOLOGICAL

Mesenchymal allogenic cells + ICOVIR-5: 500.000 cells/kg

AloCELYVIR

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• 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.
• Patient able to comply with treatment and schedule of visits and assessments
• Life expectancy of ≥8 weeks.

You may not qualify if:

• 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
• \. Washout period respect to previous treatments:
• At least two weeks since the last dose of chemotherapy. For patients receiving low-dose metronomic oral chemotherapy, this period is at least one week.
• At least four weeks since the autologous hematopoietic stem cell transplant
• At least two weeks since the last focal radiotherapy or six weeks in case of cranio-spinal radiotherapy.
• At least 2 weeks or 5 half-lifes (whichever occurs first) since the last dose of a biological or investigational treatment.

Sponsors & Collaborators

• Hospital Infantil Universitario Niño Jesús, Madrid, Spain: lead
• Apices Soluciones S.L.: collaborator

Study Sites (1)

Hospital Infantil Universitario Niño Jesús

Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Diffuse Intrinsic Pontine Glioma; Medulloblastoma; Recurrence

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Stem Neoplasms; Infratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroectodermal Tumors, Primitive; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Álvaro Lassaletta Atienza, MD

  Hospital Infantil Universitario Niño Jesús

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Open, non-randomized, single-center Phase I clinical trial.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 17, 2021
• Study Start: April 19, 2021
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

ES (1)