Oncolytic Adenovirus, DNX-2401, for Naive Diffuse Intrinsic Pontine Gliomas
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|ClinicalTrials.gov Identifier: NCT03178032|
Recruitment Status : Unknown
Verified July 2020 by Clinica Universidad de Navarra, Universidad de Navarra.
Recruitment status was: Active, not recruiting
First Posted : June 6, 2017
Last Update Posted : July 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Brainstem Glioma Neoadjuvant Therapy||Biological: DNX-2401||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: single arm treatment DNX-2401
Single arm receiving virus DNX-2401 infusion after tumor biopsy
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.
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
|Clinica Universidad de Navarra|
|Pamplona, Navarra, Spain, 31190|
|Principal Investigator:||Jaime Gallego, MD, PhD||Clinica Universidad de Navarra|