OncoMatch/Clinical Trials/NCT06264388
DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma
Is NCT06264388 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including DB107-RRV and DB107-FC for high grade glioma.
Treatment: DB107-RRV · DB107-FC — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Glioblastoma
Demographics
Prior therapy
Cannot have received: Gliadel wafer
The patient intends to undergo treatment with the Gliadel® wafer at the time of this surgery or has received the Gliadel® wafer < 30 days from surgery.
Cannot have received: cytosine arabinoside
Recent use of cytosine arabinoside (< 3 weeks).
Cannot have received: bevacizumab
Recent treatment with bevacizumamab (< 3 weeks).
Cannot have received: temozolomide
Recent treatment with temozolomide (<4 weeks).
Cannot have received: investigational medication or device
Patients who are currently receiving investigational medications or medical device(s) within 4 weeks (or 5 half-lives of the investigational medication(s), whichever is shorter) prior to enrollment.
Lab requirements
Blood counts
Platelet count ≥ 80,000, hemoglobin ≥10 g/dL, ANC > 1,500 cells/mm3, ALC > 500/mm3; patients with bone marrow depression excluded
Kidney function
eGFR > 50 mL/min (Cockcroft Gault Formula); patients with impaired renal function (eGFR < 50 cc/min) excluded
Liver function
total bilirubin < 1.5 ULN, ALT < 2.5 ULN, AST or ALT > 3 ULN and total bilirubin > 1.5 mg/dL excluded
Laboratory values (Platelet count ≥ 80,000, hemoglobin [Hg] ≥10 g/dL, absolute neutrophil count (ANC) > 1,500 cells/mm3, absolute lymphocyte count (ALC) > 500/mm3) and adequate liver function, total bilirubin< 1.5 upper limit of normal (ULN), alanine transaminase (ALT) <2.5 ULN. Estimated glomerular filtration rate (eGFR) should be > 50 mL/min (Cockcroft Gault Formula). Patients with aspartate transaminase (AST) or ALT values >3 ULN and total bilirubin >1.5 mg/dL will be excluded. Patients with bone marrow depression, such as those with a hematological disease or who are being treated with radiation or drugs that depress bone marrow or individuals who have a history of treatment with drugs or radiation that depress bone marrow within 1 month of enrollment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami Hospital · Miami, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06264388 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior Gliadel wafer, cytosine arabinoside, bevacizumab disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages