Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.

Recruiting now · Phase 1

Conditions studied: Malignant Glioma of Brain, Astrocytoma, Malignant Astrocytoma, Brain Tumor, Glioma, Brain Cancer, Glioblastoma, Glioblastoma Multiforme, GBM

In brief

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.

Key facts

Study ID: NCT05686798
Run by: Henry Ford Health System
People needed: 18
Starts: 2022-11-29
Expected to finish: 2027-12-01
Last updated by the study team: 2025-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects with radiologic evidence of intracranial recurrence or progression of a previously diagnosed high-grade astrocytoma.
To be eligible for this trial, the subjects must have:
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.
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).
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.

You may not qualify if…

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.

Where it is running

Henry Ford Health System — Detroit, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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