Actively Recruiting
Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.
Led by Henry Ford Health System · Updated on 2025-12-16
18
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Radiologic evidence of intracranial recurrence or progression of a previously diagnosed high-grade astrocytoma
- Histologically confirmed glioblastoma or anaplastic astrocytoma prior to surgery
- At least 3 months since last radiation therapy
- At least 4 weeks since last non-nitrosourea chemotherapy or 6 weeks since nitrosourea chemotherapy
- Ability to provide informed consent and willingness to follow study requirements
- Recovery from prior therapy toxicity to grade 2 or less
- Eligible for partial or total resection of recurrent tumor
- No physical connection between post-resection tumor cavity and cerebral ventricle
- Karnofsky performance status of 60 or higher at surgery
- No prior gene or virus therapy, immunotherapy, brachytherapy, or chemotherapeutic polymer implants on tumor
- No immunosuppressive or immune disorder
- Adequate baseline organ function based on lab tests
- Candidates for surgical debulking based on multidisciplinary evaluation
- 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; liver enzymes SGOT and SGPT less than 2.5 times upper limit of normal
- Women of childbearing potential must use birth control during treatment and for 90 days after surgery
- Men must use barrier protection during treatment and for 90 days after surgery
You will not qualify if you...
- Acute infection requiring treatment with fever > 38.5°C or significant leukocytosis
- Positive HIV antibodies
- History of liver disease including autoimmune or viral hepatitis
- Positive Hepatitis B or C test at baseline
- Immunosuppressive therapy except corticosteroids
- Serious medical or psychiatric illness that may interfere with treatment or study completion
- Impaired immunity or susceptibility to serious viral infections
- Pregnant or breastfeeding females
- Allergy to any study product
- Unable to undergo brain MRI
- Not eligible for surgical removal of recurrent tumor
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
Research Team
T
Tobias Walbert, MD, PhD
CONTACT
N
Nyati Shyam, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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