← Back to Search

Virus Therapy

DB107-RRV + DB107-FC for Brain Tumors

Phase 1 & 2
Waitlist Available
Led By Noriyuki Kasahara, MD, PhD
Research Sponsored by Nicholas Butowski
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Participant is between 18 years of age and 75 years of age, inclusive
Must not have
Prior treatment for High Grade Glioma (HGG)
Histological confirmed oligodendroglioma (IDH-mutant and 1p.19q-codeleted) or mixed glioma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

Summary

This trial will test a new treatment, DB107-RRV and DB107-FC, in combination with standard care for patients with newly diagnosed High Grade Glioma (HGG) following surgical

Who is the study for?
This trial is for newly diagnosed High Grade Glioma patients who have undergone maximum surgical resection. It's suitable for those with MGMT methylated tumors receiving radiation and Temozolomide per the Stupp Protocol, or just radiation therapy if unmethylated.
What is being tested?
The study tests DB107-RRV and DB107-FC after surgery in comparison to historical data. Patients will receive these treatments along with standard care, which includes radiation and possibly Temozolomide, depending on their tumor type.
What are the potential side effects?
Potential side effects may include typical reactions from Radiation Therapy and Temozolomide such as nausea, fatigue, hair loss, skin irritation at the treatment site, headaches, seizures or blood cell count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old.
Select...
My primary tumor can be tested for specific genetic changes.
Select...
I am able to care for myself but may not be able to do active work.
Select...
My brain tumor is newly diagnosed and untreated.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have received treatment for a high-grade brain tumor before.
Select...
My brain tumor is a specific type called oligodendroglioma or mixed glioma.
Select...
My brain tumor is large, spread widely, or has multiple focal points.
Select...
I have Hepatitis B, C, or both.
Select...
I cannot stop my blood thinning medication for surgery.
Select...
I am HIV positive.
Select...
I can swallow and absorb medications properly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Median Progression free survival (PFS) by biomarker status (Phase IIa)
Proportion of participants with dose limiting toxicities (Phase I)
Proportion of participants with treatment-emergent adverse events (Phase I)
Secondary study objectives
Median Overall Survival (OS) (Phase IIa)
Median Overall Survival (OS) at 6 months (Phase IIa)
Median Progression-free survival (PFS) (Phase IIa)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: No MGMT Methylation (DB107-RRV, DB107-FC, Radiation therapy)Experimental Treatment6 Interventions
Participants receive a 4.0 x 10\^8 transduction units per milliliter (TU/mL)) dose of DB107-RRV intracranially (IC) at resection and a 1.4 x 10\^9 TU/mL dose IV prior to leaving surgery room. Participants have up to 6 weeks for surgical recovery. Unmethylated MGMT participants receive 300 mg/kg/day DB107-FC PO during RT over 5 days during weeks 1-2, \& 5-6. 2Gy/day standard of care (SOC) RT will be given for 5 consecutive days for 6 weeks. After RT, participants receive 1.4 x 10\^9 TU/mL of DB107-RRV IV on days 7 and 14 and continue during a 4-week rest period between RT and adjuvant therapy. Participants who begin adjuvant therapy receive 300 mg/kg/day DB107-FC PO on days 1-5 of a 28-day cycle up to 6 cycles or until PD. Participants with no PD during adjuvant treatment may receive additional cycles of DB107-FC until PD, withdrawal, death or study closure. Participants will be followed up for safety and survival status for up to 15 years.
Group II: Low to High MGMT Methylation (DB107-RRV, DB107-FC, Temozolomide (TMZ), Radiation therapy)Experimental Treatment6 Interventions
Participants receive a 4.0 x 10\^8 TU/mL dose of DB107-RRV IC at resection and a 1.4 x 10\^9 TU/mL dose IV prior to prior to leaving surgery room. Participants have up to 6 weeks for surgical recovery. Low to high MGMT methylation participants receive 75 mg/m\^2 TMZ per SOC and 300mg/kg/day DB107-FC PO concurrent with 2Gy/day over 5 consecutive days during weeks 1-2, \& 5-6. After RT, participants receive 1.4 x 10\^9 TU/mL DB107-RRV IV on days 7 and 14. IV DB107-RRV occurs during a 4-week rest period between RT and adjuvant portions of the protocol. Participants who begin adjuvant therapy receive 300 mg/kg/day DB107-FC PO on days 1-5 of a 28-day cycle for up to 6 cycles or until PD with 150-200 mg/m\^2 adjuvant TMZ per SOC on days 1-5 of each cycle for up to 6 cycles. Participants with no PD may continue to receive additional cycles of DB107-FC PD, withdrawal, death or study closure. Participants will be followed up for safety and survival status for up to 15 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging (MRI)
2015
Completed Phase 4
~1800
Radiation Therapy (RT)
2008
Completed Phase 2
~230
Temozolomide
2010
Completed Phase 3
~1880
Surgical resection
2021
Completed Phase 2
~1740

Find a Location

Who is running the clinical trial?

Nicholas ButowskiLead Sponsor
2 Previous Clinical Trials
62 Total Patients Enrolled
California Institute for Regenerative Medicine (CIRM)OTHER
68 Previous Clinical Trials
3,249 Total Patients Enrolled
Noriyuki Kasahara, MD, PhDPrincipal InvestigatorCalifornia Institute for Regenerative Medicine (CIRM)
~47 spots leftby Nov 2039
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top