Oncolytic Adenovirus, DNX-2401, for Naive Diffuse Intrinsic Pontine Gliomas
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ClinicalTrials.gov Identifier: NCT03178032 |
Recruitment Status :
Active, not recruiting
First Posted : June 6, 2017
Last Update Posted : July 16, 2020
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Condition or disease | Intervention/treatment | Phase |
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Brainstem Glioma Neoadjuvant Therapy | Biological: DNX-2401 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I Trial of DNX-2401 for Diffuse Intrinsic Pontine Glioma Newly Diagnosed in Pediatric Patients. |
Actual Study Start Date : | May 26, 2017 |
Estimated Primary Completion Date : | January 31, 2021 |
Estimated Study Completion Date : | January 31, 2021 |

Arm | Intervention/treatment |
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Experimental: single arm treatment DNX-2401
Single arm receiving virus DNX-2401 infusion after tumor biopsy
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Biological: DNX-2401
Brain infusion of the virus through the cerebellar peduncle
Other Name: Delta-24 |
- Safety, tolerability and toxicity of DNX-2401 injected in the cerebellar peduncle [ Time Frame: 12 weeks after virus injection ]The trial will look for hematologic and neurologic toxicity (NCI-CTCAE v 4.03).
- OS12 [ Time Frame: 12 months after virus injection ]Overall Survival at 12 months
- Images response [ Time Frame: 12 months after virus injection ]Complete/partial response in MRI
- QoL [ Time Frame: 12 months after virus injection ]measure quality of life baseline assessment and any changes over time
- Samples collection [ Time Frame: 12 weeks after virus injection ]Collect tumor and blood samples for futures molecular and immune studies.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 1 Year to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Informed consent OF PATIENT OR PARENTS
- Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
- Age 1 - 18 years
- Negative pregnant blood test in case of fertile women (A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- Patient newly diagnosed of DIPG in MRI
- Lansky Performance Status ≥ 70 before inclusion
- Lesion considered by the investigator to be accessible for stereotactic biopsy. Lesion location will allow injection without entrance of virus in the ventricular system.
- No previous treatment for DIPG
Exclusion Criteria:
- Severe infections or intercurrent medical conditions including, but not limited to, severe renal, hepatic, heart or bone marrow failure, that, on investigator´s criteria, do not allow the inclusion. Patients must be afebrile at baseline [i.e., < 38 degrees (Cº)].
- Investigational medication in the previous 30 days.
- Subjects with immunodeficiency, autoimmune conditions or active hepatitis.
- Any medical or psychological condition that might interfere with the subject's ability to participate if older than 16 years or parents ability when younger than 16, or give informed consent or would compromise the patient's ability to tolerate therapy or any disease that will obscure toxicity or dangerously alter drug metabolism.
- Tumor with multiple locations or doubt in MRI of a DIPG.
- Pregnant or breast-feeding females will be excluded, due to the risk for the fetal development of a recombinant virus containing genes related to cellular growth and differentiation.
- Severe bone marrow hypoplasia.
- AST (aspartate transaminase) and/or ALT (alanine transaminase)> 3 times over upper normal laboratory level
- Neutrophils < 1 x 109/L
- Thrombocytes ≤ 100 x 109/L
- Hemoglobin < 9g/dl
13. Patients with Li-Fraumeni Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways.
14. Vaccinations of any kind within 30 days prior to DNX-2401 administration. 15. Transfusions or medications (G-CSF) to treat pancytopenia or other hematological conditions within 28 days of baseline.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178032
Spain | |
Clinica Universidad de Navarra | |
Pamplona, Navarra, Spain, 31190 |
Principal Investigator: | Jaime Gallego, MD, PhD | Clinica Universidad de Navarra |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Clinica Universidad de Navarra, Universidad de Navarra |
ClinicalTrials.gov Identifier: | NCT03178032 |
Other Study ID Numbers: |
D24-DIPG |
First Posted: | June 6, 2017 Key Record Dates |
Last Update Posted: | July 16, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | During the trail the results will be presented in scientific meetings. After the trial, a paper will be published by the IP |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Diffuse intrinsic pontine gliomas Oncolytic adenovirus |
Glioma Diffuse Intrinsic Pontine 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 |