Actively Recruiting
DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma
Led by Ashish Shah · Updated on 2025-05-29
33
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
Sponsors
A
Ashish Shah
Lead Sponsor
D
Denovo Biopharma LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine if the investigational products, DB107-RRV and DB107-FC, as a combination treatment will shrink high-grade glioma (HGG) in patients with recurrent/progressive, resectable or unresectable disease and increase the time that disease is controlled.
CONDITIONS
Official Title
DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18-75 years old
- Histologically proven high-grade glioma with first or second recurrence
- Patients with resectable or unresectable glioblastoma or anaplastic astrocytoma
- Measurable disease on MRI with at least 1 cm in two dimensions
- Last temozolomide treatment at least 4 weeks before surgery
- Prior radiation therapy allowed with recurrence confirmation by biopsy or MRI
- Presence of Denovo Genomic Marker 7 (DGM7) biomarker in blood
- Adequate blood counts and liver function (platelets ≥ 80,000; hemoglobin ≥ 10 g/dL; neutrophils > 1,500/mm3; lymphocytes > 500/mm3; bilirubin < 1.5 ULN; ALT < 2.5 ULN; eGFR > 50 mL/min)
- Not pregnant and willing to use effective contraception during and 12 months after treatment
- Karnofsky Performance Score ≥ 70
- Able to consent and follow study protocol
You will not qualify if you...
- History of other active cancers within 5 years except certain skin, cervical, or prostate cancers
- Multifocal gliomas not suitable for biopsy or treatment, or 3 or more intracranial recurrences
- Oligodendroglioma or mixed gliomas confirmed by histology
- HIV infection or severe immunosuppression
- Impaired kidney function (eGFR < 50 cc/min)
- Bone marrow depression or recent treatments that depress bone marrow
- Planned or recent Gliadel wafer treatment within 30 days
- Allergy to flucytosine (5-FC)
- Gastrointestinal diseases affecting medication absorption
- Pregnancy or breastfeeding
- Recent use of cytosine arabinoside, bevacizumab, or temozolomide within specified weeks
- Bleeding disorders or anticoagulant/antiplatelet use that cannot be stopped for surgery
- High-dose dexamethasone use before surgery
- Severe heart or lung diseases or other conditions affecting compliance
- Active infection requiring systemic therapy recently
- Current COVID-19 infection
- Impaired decision-making ability
- Use of investigational drugs or devices within 4 weeks
- Other metabolic or psychological diseases affecting compliance or risk
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Miami Hospital
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
L
Leonela Wright, MSN, RN
CONTACT
A
Ashish Shah, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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