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Virus Therapy
Low to High MGMT Methylation (DB107-RRV, DB107-FC, Temozolomide (TMZ), Radiation therapy) for Brain Tumor
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
1. Participant has provided written informed consent.
2. Participant is between 18 years of age and 75 years of age, inclusive.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights
Summary
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. This study is going to be conducted in newly diagnosed HGG patients receiving with maximum surgical resection treatment followed by radiation and temozolomide treatment using the established Stupp Protocol for O6-methylguanine-DNA methyl-transferase (MGMT) methylated patients or radiation therapy for MGMT unmethylated patients.
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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
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 moreTrial 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
Radiation Therapy (RT)
2008
Completed Phase 2
~230
Temozolomide
2010
Completed Phase 3
~1930
Magnetic Resonance Imaging (MRI)
2015
Completed Phase 4
~1800
Surgical resection
2021
Completed Phase 2
~920
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
67 Previous Clinical Trials
3,199 Total Patients Enrolled
Noriyuki Kasahara, MD, PhDPrincipal InvestigatorCalifornia Institute for Regenerative Medicine (CIRM)
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