RecruitingPhase 1NCT05686798

Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.

Phase I Study of Replication-Competent Adenovirus-Mediated Double Suicide Gene Therapy With Stereotactic Radiosurgery in Patients With Recurrent or Progressive High Grade Astrocytomas


Sponsor

Henry Ford Health System

Enrollment

18 participants

Start Date

Nov 29, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The primary goal of this Phase I study is to determine the maximum tolerated dose of oncolytic adenovirus mediated double suicide-gene therapy in combination with fractionated stereotactic radiosurgery in patients with recurrent high-grade astrocytoma undergoing resection.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of gene therapy and radiation for people with brain tumors called high-grade astrocytomas (including glioblastoma) that have grown back after initial treatment. A specially engineered virus is injected into the tumor during surgery to help destroy cancer cells alongside radiation. **You may be eligible if...** - You are 18 or older - You have a high-grade astrocytoma or glioblastoma that has regrown after prior radiation and chemotherapy - At least 3 months have passed since your last radiation treatment - Your tumor can be surgically removed or debulked again - Your general functioning is reasonably good (Karnofsky score ≥ 60) - You have not previously received gene therapy, viral therapy, or brain implants for this tumor **You may NOT be eligible if...** - You have had prior gene therapy or viral therapy for any brain tumor - Your tumor is directly connected to the brain ventricles (fluid-filled spaces) - You have an immune system disorder or are on immunosuppressive drugs - Your organ function does not meet minimum requirements - You cannot consent or meet all study requirements 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

BIOLOGICALAd5-yCD/mutTKSR39rep-ADP adenovirus and fractionated stereotactic radiosurgery (fSRS)

Ad5-yCD/mutTKSR39rep-ADP adenovirus will be injected intratumoral


Locations(1)

Henry Ford Health System

Detroit, Michigan, United States

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NCT05686798


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