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Adenovirus Gene Therapy and Radiation for Progressive Astrocytoma

This study is testing a new approach for people with recurrent high-grade astrocytoma (a type of brain tumor). It combines a modified virus called Ad5-yCD/mutTKSR39rep-ADP adenovirus, which is injected directly into the tumor area after surgery, with oral medications (5-fluorocytosine and valganciclovir) and radiation therapy (fSRS). The main goal of this first-phase study is to find the highest safe dose of the adenovirus. You may be able to join if you have a high-grade astrocytoma that has come back or grown, and you are scheduled for surgery. The study is currently unclear on its recruitment status and plans to enroll 18 participants.

Study design
This is an interventional study with a planned enrollment of 18 participants. It is a single-arm study, meaning all participants receive the same treatment.
What's involved
After tumor removal surgery, you will receive an injection of the adenovirus, oral medications, and fractionated stereotactic radiosurgery (fSRS). You will be monitored for 30 days after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for 30 days after treatment before starting their next anti-cancer therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05686798

Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.

Recruiting
PHASE1Ages 18+InterventionalTreatment
Henry Ford Health System
~18 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:Ad5-yCD/mutTKSR39rep-ADP adenovirus and fractionated stereotactic radiosurgery (fSRS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose
Measured over 30 days

Conditions

Malignant Glioma of Brain
Astrocytoma
Malignant Astrocytoma
Brain Tumor
Glioma
Brain Cancer
Glioblastoma
Glioblastoma Multiforme
GBM

Explore related trials

Anaplastic AstrocytomaGlioblastoma

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Tobias Walbert, MD, PhD · PRINCIPAL_INVESTIGATOR · Henry Ford Health System

Who to contact

Tobias Walbert, MD, PhD
[email protected]
3139162723
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically documented glioblastomas or anaplastic astrocytoma prior to the debulking surgery that is suspicious to have progressed on imaging. An interval of at least 3 months must have elapsed since the completion of the most recent course of radiation while at least 4 weeks must have elapsed since the completion of a non-nitrosourea containing chemotherapy regimen and at least 6 weeks since the completion of a nitrosourea containing chemotherapy regimen.
Patients must be ≥ 18 years of age, able to provide informed consent and express a willingness to meet all the expected requirements of the protocol for the duration of the study.
Must have recovered from toxicity (grade 2 or less) of prior therapy.
Eligible for partial or total resection of the recurrent tumor
No anticipated physical connection between post-resection tumor cavity and cerebral ventricle
Karnofsky performance status (KPS) ≥ 60 at time of surgery
No prior treatment of the tumor with gene or virus therapy, immunotherapy, brachytherapy, or implants of polymers containing chemotherapeutic agents (e.g. Gliadel Wafer)
No immunosuppressive or immune disorder
Baseline organ function testing intact
Patients who are candidates for surgical debulking (re-resection) following recurrence of diseases based on multidisciplinary evaluation by neurosurgeons, radiation oncologists, neuro-radiologists, and neuro-oncologists. 2. Subjects must have adequate baseline organ function, as assessed by the following laboratory values, within 30 days before initiating the study therapy:
Adequate renal function with creatinine clearance ≥ 50 mL/min/m2
Platelet count ≥ 100,000/μL
Absolute neutrophil count ≥ 1,000/μL
Hemoglobin \> 10.0 g/dL
Bilirubin \< 1.5 mg/dL; SGOT and SGPT \< 2.5 times upper limit of normal (ULN). 3. Women of child-bearing potential will be required to practice birth control for the duration of the treatment and for at least 90 days after surgery with intratumor virus inoculation. Men must use barrier protection for the duration of treatment and for at least 90 days after surgery with intratumor virus inoculation treatment.

Exclusion

Acute infection. Acute infection is defined by any viral, bacterial, or fungal infection that has required active treatment and caused oral temperature \>38.5oC and/or clinically significant leukocytosis
Serum antibodies to human immunodeficiency virus (HIV)
Previous history of liver disease including autoimmune or viral hepatitis
Positive serologic test for Hepatitis B or C at baseline
Immunosuppressive therapy except for corticosteroid use
Serious medical or psychiatric illness or concomitant medication, which, in the judgment of the investigator, might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial
Impaired immunity or susceptibility to serious viral infections
Pregnant or lactating females
Allergy to any product used on the protocol
Patient is not able to undergo a brain MRI.
Patients who are not eligible for debulking surgery or resection of recurrent disease will be considered ineligible.

What this trial measures

  • Maximum Tolerated Dose30 days

    The primary objective is to determine the maximum tolerated dose of injected of Ad5-yCD/mutTKSR39rep-ADP adenovirus into the resection cavity at the time of surgery.