RecruitingPhase 1NCT03896568

MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma

Phase I Clinical Trial of Allogeneic Bone Marrow Human Mesenchymal Stem Cells Loaded With A Tumor Selective Oncolytic Adenovirus, DNX-2401, Administered Via Intra-Arterial Injection in Patients With Recurrent High-Grade Glioma


Sponsor

M.D. Anderson Cancer Center

Enrollment

36 participants

Start Date

Feb 12, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies best dose and side effects of oncolytic adenovirus DNX-2401 in treating patients with high-grade glioma that has come back (recurrent). Oncolytic adenovirus DNX-2401 is made from the common cold virus that has been changed in the laboratory to make it less likely to cause an infection (such as a cold). The virus is also changed to target brain cancer cells and attack them.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an innovative approach for recurrent brain cancer (glioblastoma or high-grade glioma): using specially engineered stem cells loaded with a cancer-killing virus (DNX-2401) to directly target tumors that have returned after initial treatment. The stem cells act as delivery vehicles, traveling through the brain to find and deliver the virus to tumor cells. **You may be eligible if...** - You have a confirmed diagnosis of recurrent glioblastoma, gliosarcoma, anaplastic astrocytoma (IDH wild-type), or IDH-mutant grade 4 astrocytoma - Your tumor has come back after initial treatment - Your tumor is at least 1 cm and no more than 5 cm in diameter - You are in good general health and able to give informed consent **You may NOT be eligible if...** - Your tumor has spread widely or is rapidly growing outside the main mass - You require immune-suppressing doses of steroids - You are pregnant or breastfeeding - You have active infections or serious other medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALOncolytic Adenovirus Ad5-DNX-2401

Given IA

PROCEDURETherapeutic Conventional Surgery

Undergo surgery


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT03896568


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