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 (May 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
Cancer type
Glioblastoma
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 →
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