BridgeMD
New treatment option for High Grade Glioma
Official title DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma
ClinicalTrials.gov ID: NCT06264388
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.
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
- 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.
- 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 to 75
You may be able to join if
- Patients 18-75 years old.
- Histologically proven HGG that have recurred/progressed (first or second recurrence).
- Patients with unresectable or resectable HGG (AA or GBM) will be enrolled.
- Measurable disease on MRI as evidenced by 1 cm on two separate dimensions on MRI fluid attenuated inversion recovery (FLAIR) (non-enhancing) or...
- Last temozolomide dosage 4 weeks prior to surgery.
You likely can't join if
- History of active other malignancy (other than non-melanoma skin cancers, cervical ductal carcinoma in situ or localized prostate cancer) within 5...
- Multifocal gliomas that cannot undergo stereotactic biopsy/administration of DB107-RRV will be excluded. Patients with 3 or more intracranial...
- Histologically confirmed oligodendroglioma or mixed gliomas.
- History of human immunodeficiency virus (HIV) infection or other forms of severe immunosuppression.
- Patients with impaired renal function (eGFR\<50 cc/min).
- Patients with bone marrow depression, such as those with a hematological disease or who are being treated with radiation or drugs that depress bone...
See the full eligibility criteria
- Patients 18-75 years old.
- Histologically proven HGG that have recurred/progressed (first or second recurrence).
- Patients with unresectable or resectable HGG (AA or GBM) will be enrolled.
- Measurable disease on MRI as evidenced by 1 cm on two separate dimensions on MRI fluid attenuated inversion recovery (FLAIR) (non-enhancing) or contrast-enhancement.
- Last temozolomide dosage 4 weeks prior to surgery.
- Patients with prior radiation therapy are allowed, but histological tumor diagnosis of recurrent tumor must be confirmed according to the RANO criteria. Recurrence must be confirmed by diagnostic biopsy with local...
- Presence of Denovo Genomic Marker 7 (DGM7) biomarker in blood.
- 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\ 50...
- Patients cannot be pregnant at the time of enrollment or during the study. Patients willing to use one (1) effective method of contraception in addition to barrier methods (condoms) from the time of signing the informed...
- Karnofsky Performance Score (KPS) ≥ 70.
- Patient is able to consent and abide by protocol.
- History of active other malignancy (other than non-melanoma skin cancers, cervical ductal carcinoma in situ or localized prostate cancer) within 5 years.
- Multifocal gliomas that cannot undergo stereotactic biopsy/administration of DB107-RRV will be excluded. Patients with 3 or more intracranial recurrences will be excluded.
- Histologically confirmed oligodendroglioma or mixed gliomas.
- History of human immunodeficiency virus (HIV) infection or other forms of severe immunosuppression.
- Patients with impaired renal function (eGFR\<50 cc/min).
- 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...
- 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.
- Allergy to 5-FC.
- Gastrointestinal diseases that prevent absorption of medications such as 5-FC.
- Pregnancy or patients who are actively breast-feeding.
- Recent use of cytosine arabinoside (\< 3 weeks).
- Recent treatment with bevacizumamab (\< 3 weeks).
- Recent treatment with temozolomide (\<4 weeks).
- History of bleeding diathesis or current anti-coagulant or anti-platelet usage, including nonsteroidal anti-inflammatory drugs (NSAIDs), at the time of the scheduled resection that cannot be stopped for surgery.
- Sustained dependence on systemic dexamethasone (\>8 mg/day) one month prior to surgery.
- Severe systemic illnesses including cardiopulmonary dysfunction (New York Heart Association \> Grade 2 congestive heart failure (CHF), uncontrolled arrhythmias, significant pulmonary disease \> Grade 2 dyspnea) or other...
- The patient has or had any active infection requiring systemic antibiotic, antifungal or antiviral therapy within the past 4 weeks.
- Current or active coronavirus disease (COVID-19) disease, positive quantitative polymerase chain reaction (qPCR) result.
- Patients with impaired decision-making capacity.
- 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.
- Patients who have any other disease, either metabolic or psychological, which as per Investigator assessment may affect the patient's compliance or place the patient at higher risk of potential treatment complications.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, 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.