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New treatment option for High Grade Glioma
Official title DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma
ClinicalTrials.gov ID: NCT06504381
What this study is testing
What is DB107-RRV?
DB107-RRV is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for high grade glioma.
Also referred to as Toca 511, Vocimagene amiretrorepvec.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, open-label study of DB107-RRV (formerly Toca 511) and DB107-FC (formerly Toca FC) when administered following surgical resection in newly diagnosed High Grade Glioma (HGG) patients. The study is designed to evaluate whether treatment with DB107-RRV in combination with DB107-FC when added to standard of care provides clinical benefit to newly diagnosed HGG when compared to historical performance previously determined in well controlled clinical trials published in the peer reviewed literature.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Each patient must meet all of the following to be eligible for study entry:
- Participant has provided written informed consent.
- Participant is between 18 years of age and 75 years of age, inclusive.
- Participant must have a Karnofsky Performance Scale (KPS) of \>= 70.
- Participant must have newly diagnosed adult-type diffuse gliomas (World Health Organization Classification 2021) that has not been previously treated...
You likely can't join if
- Participants may not meet any of the following exclusion criteria to be eligible for study entry:
- Prior treatment for High Grade Glioma (HGG).
- History of other malignancy unless the participant has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous...
- Histological confirmed oligodendroglioma (IDH-mutant and 1p.19q-codeleted) or mixed glioma.
- A contrast-enhancing brain tumor that is any of the following:
- Multi-focal (defined as 2 separate areas of presumed tumor whether contrast enhancing or not, measuring at least 1cm in 2 planes that are not...
See the full eligibility criteria
- Each patient must meet all of the following to be eligible for study entry:
- Participant has provided written informed consent.
- Participant is between 18 years of age and 75 years of age, inclusive.
- Participant must have a Karnofsky Performance Scale (KPS) of \>= 70.
- Participant must have newly diagnosed adult-type diffuse gliomas (World Health Organization Classification 2021) that has not been previously treated with surgery, radiation or chemotherapy (specifically astrocytoma...
- Based on the pre-operative evaluation by neurosurgeon, participant is a candidate for \>= 80% resection of the enhancing region.
- The primary tumor must be made available for central testing for IDH1 mutation, O6-methylguanine-DNA methyl-transferase (MGMT) methylation status.
- Willing to provide a blood sample to determine Denovo Genomic Marker 7 (DGM7) status.
- Laboratory values adequate for patient to undergo surgery, including:
- Platelet count \>= 60,000/mm\^3
- Hemoglobin \>= 10 g/dL
- Absolute neutrophil count (ANC) \>= 1,500/mm\^3
- Absolute lymphocyte count \>= 500/mm\^3
- Total bilirubin \<=1.5 x upper limit of normal (ULN) (unless patient had Gilbert's syndrome)
- alanine aminotransferase (ALT) \<= 2.5 x ULN
- Estimated glomerular filtration rate of at least 50 mL/min by Cockcroft Gault Formula
- Female participants of child-bearing potential and male participants must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30-days prior to the first administration of...
- A female of child-bearing potential is any women (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy or
- Has not had \>= 12 months of non-therapy-induced amenorrhea.
- Participants must not be breastfeeding.
- Participants must have the ability to understand, and the willingness to comply with the scheduled visits, treatment schedule, laboratory testing and other requirements of the study.
- Participants may not meet any of the following exclusion criteria to be eligible for study entry:
- Prior treatment for High Grade Glioma (HGG).
- History of other malignancy unless the participant has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is not exclusionary regardless of time, as well as...
- Histological confirmed oligodendroglioma (IDH-mutant and 1p.19q-codeleted) or mixed glioma.
- A contrast-enhancing brain tumor that is any of the following:
- Multi-focal (defined as 2 separate areas of presumed tumor whether contrast enhancing or not, measuring at least 1cm in 2 planes that are not contiguous
- Associated with either diffuse subependymal or leptomeningeal dissemination or
- \> 5cm in any dimension.
- Participant has or had an active infection requiring antibiotic, antifungal or antiviral therapy in the 4 weeks preceding study Cycle 1: Day 1.
- Participant has any bleeding diathesis, or must take anticoagulants, or antiplatelet agents, including nonsteroidal anti-inflammatory drugs (NSAIDs), at the time of the scheduled resection that cannot be interrupted for...
- Participant is HIV positive.
- Participant has Hepatitis B (positive test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and positive test for hepatitis B Virus (HBV) DNA) or Hepatitis C (positive tests for hepatitis C...
- Participant has a history of allergy or intolerance to flucytosine (DB107-FC).
- Participant has a gastrointestinal disease that would, in the opinion of the Investigator, prevent him or her from being able to swallow or absorb flucytosine.
- Participant intends to undergo treatment with the Gliadel® wafer at the time of resection surgery or has received Gliadel® wafer \< 30 days from Cycle 1: Day 1.
- Severe pulmonary, cardiac or other systemic disease, which as per Investigator assessment would prevent surgical resection.
- Participant who have any other disease or condition, which as per Investigator assessment may affect the participant's compliance or place the participant at higher risk of potential treatment complications.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Miami, Florida, United States
- Lake Success, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Diego, California, United States; San Francisco, California, United States; Miami, Florida, United States; Lake Success, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.