Actively Recruiting
DB107-RRV and DB107-FC With Radiation Therapy With or Without Temozolomide for Newly Diagnosed High Grade Glioma
Led by University of California, San Francisco · Updated on 2026-03-11
70
Participants Needed
5
Research Sites
730 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
C
California Institute for Regenerative Medicine (CIRM)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of DB107-RRV and DB107-FC along with standard treatments in patients newly diagnosed with High Grade Glioma (HGG), a type of brain tumor. This open-label, multicenter study aims to see if adding these investigational therapies after surgery and during radiation or chemotherapy offers clinical benefits compared to historical data. The study involves patients receiving maximum surgical tumor removal followed by radiation and temozolomide or radiation alone depending on their MGMT methylation status. Participants receive DB107-RRV directly into the brain during surgery and intravenously shortly afterward. Those without MGMT methylation get DB107-FC orally during radiation therapy, while those with low to high MGMT methylation receive DB107-FC alongside temozolomide and radiation. After radiation, additional doses of DB107-RRV are given intravenously, followed by cycles of DB107-FC with or without temozolomide based on patient group. Treatment continues until disease progression or study end, with some participants able to receive extended DB107-FC cycles. The study includes two phases: Phase I focuses on safety and dosing, and Phase IIa evaluates effectiveness and long-term outcomes. Participants will undergo tumor resection and receive radiation and drug treatments according to group assignment. Researchers will monitor safety, adverse events, and tumor response using imaging and biomarker tests, including MGMT methylation and IDH1 mutation status. Blood samples will be collected for genomic marker analysis. The study tracks progression-free survival and overall survival up to 15 years. Regular assessments include clinical exams, laboratory tests, and imaging to evaluate treatment effects and patient health throughout the study.
CONDITIONS
Brief Title
DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Between 18 and 75 years of age, inclusive
- Karnofsky Performance Scale (KPS) score of 70 or higher
- Newly diagnosed adult-type diffuse glioma not previously treated with surgery, radiation, or chemotherapy
- Candidate for at least 80% surgical tumor resection based on neurosurgeon evaluation
- Primary tumor available for central testing of IDH1 mutation and MGMT methylation status
- Willing to provide blood sample for Denovo Genomic Marker 7 (DGM7) status
- Adequate lab values for surgery including platelet count ≥ 60,000/mm³, hemoglobin ≥ 10 g/dL, ANC ≥ 1,500/mm³, lymphocyte count ≥ 500/mm³, bilirubin ≤ 1.5x upper limit of normal (ULN), ALT ≤ 2.5x ULN, and estimated glomerular filtration rate ≥ 50 mL/min
- Agree to use adequate contraception during and after the study as specified
- Not breastfeeding
- Able and willing to comply with study visits, treatment, and testing requirements
You will not qualify if you...
- Prior treatment for High Grade Glioma
- History of other malignancy unless disease-free for at least 5 years, except certain treated skin or localized cancers
- Histologically confirmed oligodendroglioma or mixed glioma
- Multifocal brain tumor or tumor larger than 5 cm or with diffuse spread
- Active infection requiring treatment within 4 weeks before starting study
- Bleeding disorders or use of anticoagulants or antiplatelet agents that cannot be stopped for surgery
- HIV positive status
- Hepatitis B or C infection or co-infection
- Allergy or intolerance to flucytosine (DB107-FC)
- Gastrointestinal disease preventing swallowing or absorption of flucytosine
- Planned or recent Gliadel® wafer treatment within 30 days
- Severe pulmonary, cardiac, or systemic disease preventing surgery
- Other medical conditions that may affect compliance or increase risk of complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants undergo tumor resection surgery during which DB107-RRV is given intracranially, followed by an intravenous dose immediately after surgery. Participants then have up to 6 weeks for surgical recovery.
1 surgery visit and recovery period
Duration - Up to approximately 6 months or until disease progression
Participants receive DB107-FC orally and radiation therapy over 6 weeks. Participants with Low to High MGMT methylation also receive Temozolomide during this period. After radiation therapy, participants receive intravenous DB107-RRV on days 7 and 14 during a 4-week rest period before starting adjuvant therapy. Adjuvant therapy includes cycles of DB107-FC and, for the methylated group, Temozolomide, continuing until disease progression or withdrawal.
Weekly visits during radiation therapy, additional visits during rest and adjuvant therapy cycles
Duration - Up to 15 years
Participants are followed for safety and survival status for up to 15 years after treatment completion.
Periodic visits for long-term monitoring
Trial Site Locations
Total: 5 locations
1
University of Southern California
Los Angeles, California, United States, 90089
Actively Recruiting
2
University of California, San Diego
San Diego, California, United States, 92093
Actively Recruiting
3
University of California
San Francisco, California, United States, 94143
Actively Recruiting
4
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
5
Northwell Health
Lake Success, New York, United States, 11042
Actively Recruiting
Research Team
S
Stephanie Lewis, RN
N
Neuro-Oncology New Patient Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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