Study on DB107-Retroviral Vector and DB107-Flucytosine for Patients with Recurrent Glioblastoma or Anaplastic Astrocytoma

Inclusion Criteria

• Adults aged 18 to 75 years.
• Diagnosed with high-grade glioma (HGG) that has returned or progressed after initial treatment.
• Tumors can be either operable or inoperable.
• Tumors must be measurable on an MRI scan.
• Last dose of temozolomide must have been at least 4 weeks before surgery.
• Previous radiation therapy is allowed, but the tumor must be confirmed as recurrent by biopsy or MRI.
• Must have a specific genetic marker called Denovo Genomic Marker 7 (DGM7) in the blood.
• Must have adequate blood counts and liver function.
• Must not be pregnant and must agree to use effective contraception during and after the study.
• Must have a Karnofsky Performance Score of 70 or higher, indicating the ability to care for oneself.
• Must be able to understand and agree to the study requirements.

Exclusion Criteria

• History of another active cancer within the last 5 years, except for certain skin or prostate cancers.
• Multiple brain tumors that cannot be biopsied or treated with the study drug.
• Certain types of brain tumors like oligodendroglioma.
• History of HIV or other severe immune system issues.
• Poor kidney function.
• Bone marrow issues or recent treatments that affect bone marrow.
• Recent use of certain cancer treatments or medications.
• Allergy to the study drug 5-FC.
• Digestive issues that prevent medication absorption.
• Pregnant or breastfeeding women.
• Recent infections or current COVID-19 infection.
• Dependence on high doses of certain medications like dexamethasone.
• Severe health conditions that could interfere with the study.
• Impaired decision-making ability.
• Participation in other clinical trials or use of investigational drugs recently.