[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554845":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":69,"centralContacts":75,"locations":85,"responsibleParty":167,"collaborators":170,"id":178,"slug":179,"hasResults":180,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":80,"eligibilityCriteria":184,"healthyVolunteers":180,"sex":185,"minAge":186,"maxAge":80,"enrollmentInfo":187,"targetDuration":80,"studyType":190,"phases":191,"briefSummary":194,"conditions":195,"keywords":199,"overallStatus":88,"whyStopped":80,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":211},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"No MGMT Methylation (DB107-RRV, DB107-FC, Radiation therapy)","EXPERIMENTAL","Participants receive a 4.0 x 10\\^8 transduction units per milliliter (TU\u002FmL)) dose of DB107-RRV intracranially (IC) at resection and a 1.4 x 10\\^9 TU\u002FmL dose IV prior to leaving surgery room. Participants have up to 6 weeks for surgical recovery. Unmethylated MGMT participants receive 300 mg\u002Fkg\u002Fday DB107-FC PO during RT over 5 days during weeks 1-2, \\& 5-6. 2 gray (Gy)\u002Fday 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\u002FmL 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\u002Fkg\u002Fday 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.",[13,14,15,16,17,18],"Genetic: DB107-RRV","Drug: DB107-FC","Radiation: Radiation Therapy (RT)","Drug: Temozolomide","Procedure: Magnetic Resonance Imaging (MRI)","Procedure: Surgical resection",{"label":20,"type":10,"description":21,"interventionNames":22},"Low to High MGMT Methylation (DB107-RRV, DB107-FC, Temozolomide (TMZ), Radiation therapy)","Participants receive a 4.0 x 10\\^8 TU\u002FmL dose of DB107-RRV IC at resection and a 1.4 x 10\\^9 TU\u002FmL 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\u002Fm\\^2 TMZ per SOC and 300mg\u002Fkg\u002Fday DB107-FC PO concurrent with 2 Gy\u002Fday over 5 consecutive days during weeks 1-2, \\& 5-6. After RT, participants receive 1.4 x 10\\^9 TU\u002FmL 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\u002Fkg\u002Fday DB107-FC PO on days 1-5 of a 28-day cycle for up to 6 cycles or until PD with 150-200 mg\u002Fm\\^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.",[13,14,15,16,17,18],[24,32,41,48,54,62],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"GENETIC","DB107-RRV","Given intracranially (IC) during resection and intravenously (IV) immediately following",[20,9],[30,31],"Toca 511","Vocimagene amiretrorepvec",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","DB107-FC","Given orally (PO)",[20,9],[38,39,40],"Toca FC","Extended-release 5-fluorocytosine","5-fluorocytosine",{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"RADIATION","Radiation Therapy (RT)","Undergo RT",[20,9],[47],"Radiation Treatment",{"type":33,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Temozolomide","Given PO",[20,9],[53],"Temozolomide (TMZ)",{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"PROCEDURE","Magnetic Resonance Imaging (MRI)","Undergo standard of care MRI",[20,9],[60,61],"MR","MRI",{"type":55,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"Surgical resection","Undergo non-investigational tumor resection",[20,9],[67,68],"Surgical tumor resection","Brain surgery",[70,73],{"name":71,"affiliation":5,"role":72},"Nicholas Butowski, MD","PRINCIPAL_INVESTIGATOR",{"name":74,"affiliation":5,"role":72},"Noriyuki Kasahara, MD, PhD",[76,82],{"name":77,"role":78,"phone":79,"phoneExt":80,"email":81},"Stephanie Lewis, RN","CONTACT","(415) 353-2193",null,"stephanie.lewis2@ucsf.edu",{"name":83,"role":78,"phone":80,"phoneExt":80,"email":84},"Neuro-Oncology New Patient Coordinator","NeuroOncNewPatientCoord@ucsf.edu",[86,106,121,135,151],{"facility":87,"status":88,"city":89,"state":90,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"University of Southern California","RECRUITING","Los Angeles","California","90089","United States","US",{"type":95,"coordinates":96},"Point",[97,98],-118.24368,34.05223,{"lat":98,"lon":97},[101,104],{"name":80,"role":78,"phone":102,"phoneExt":80,"email":103},"(323) 409-7422","tcchen@usc.edu",{"name":105,"role":72,"phone":80,"phoneExt":80,"email":80},"Thomas Chen, MD",{"facility":107,"status":88,"city":108,"state":90,"zip":109,"country":92,"countryCode":93,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"University of California, San Diego","San Diego","92093",{"type":95,"coordinates":111},[112,113],-117.16472,32.71571,{"lat":113,"lon":112},[116,119],{"name":80,"role":78,"phone":117,"phoneExt":80,"email":118},"858-822-5354","CancerCTO@health.ucsd.edu",{"name":120,"role":72,"phone":80,"phoneExt":80,"email":80},"David Piccioni, MD, PhD",{"facility":122,"status":88,"city":123,"state":90,"zip":124,"country":92,"countryCode":93,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"University of California","San Francisco","94143",{"type":95,"coordinates":126},[127,128],-122.41942,37.77493,{"lat":128,"lon":127},[131,132,133,134],{"name":77,"role":78,"phone":79,"phoneExt":80,"email":81},{"name":83,"role":78,"phone":80,"phoneExt":80,"email":84},{"name":71,"role":72,"phone":80,"phoneExt":80,"email":80},{"name":74,"role":72,"phone":80,"phoneExt":80,"email":80},{"facility":136,"status":88,"city":137,"state":138,"zip":139,"country":92,"countryCode":93,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"University of Miami","Miami","Florida","33136",{"type":95,"coordinates":141},[142,143],-80.19366,25.77427,{"lat":143,"lon":142},[146,149],{"name":80,"role":78,"phone":147,"phoneExt":80,"email":148},"(305) 243-0864","xw612@med.miami.edu",{"name":150,"role":72,"phone":80,"phoneExt":80,"email":80},"Ashish Shah, MD",{"facility":152,"status":88,"city":153,"state":154,"zip":155,"country":92,"countryCode":93,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Northwell Health","Lake Success","New York","11042",{"type":95,"coordinates":157},[158,159],-73.71763,40.77066,{"lat":159,"lon":158},[162,165],{"name":80,"role":78,"phone":163,"phoneExt":80,"email":164},"516-941-1260","CI-NeuroDMT@northwell.edu",{"name":166,"role":72,"phone":80,"phoneExt":80,"email":80},"Samuel Singer, MD",{"type":72,"investigatorFullName":168,"investigatorTitle":169,"investigatorAffiliation":5,"oldNameTitle":80,"oldOrganization":80},"Nicholas Butowski","Professor in Residence",[171,173,176],{"name":172,"class":6},"California Institute for Regenerative Medicine (CIRM)",{"name":174,"class":175},"Denovo Biopharma LLC","INDUSTRY",{"name":177,"class":175},"Anova Enterprises, Inc","100554845","phase-1-db107-rrv-db107-fc-and-radiation-therapy-with-or-without-temozolomide-tmz-for-high-grade-glioma-100554845",false,"NCT06504381","DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma","A Phase I\u002FIIa Study to Evaluate the Efficacy of DB107-RRV (Formerly Toca511), Administered to Subjects at Time of Resection and Intravenously Thereafter, in Combination With DB107-FC (Formerly Toca FC) and Radiation Therapy or DB107-FC, Temozolomide (TMZ) and Radiation Therapy in Patients With Newly Diagnosed High Grade Glioma","Inclusion Criteria:\n\nEach patient must meet all of the following inclusion criteria to be eligible for study entry:\n\n1. Participant has provided written informed consent.\n2. Participant is between 18 years of age and 75 years of age, inclusive.\n3. Participant must have a Karnofsky Performance Scale (KPS) of \\>= 70.\n4. 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, Isocitrate dehydrogenase (IDH)-mutant or glioblastoma, IDH-wildtype).\n5. Based on the pre-operative evaluation by neurosurgeon, participant is a candidate for \\>= 80% resection of the enhancing region.\n6. The primary tumor must be made available for central testing for IDH1 mutation, O6-methylguanine-DNA methyl-transferase (MGMT) methylation status.\n7. Willing to provide a blood sample to determine Denovo Genomic Marker 7 (DGM7) status.\n8. Laboratory values adequate for patient to undergo surgery, including:\n\n   1. Platelet count \\>= 60,000\u002Fmm\\^3\n   2. Hemoglobin \\>= 10 g\u002FdL\n   3. Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n   4. Absolute lymphocyte count \\>= 500\u002Fmm\\^3\n   5. Total bilirubin \\\u003C=1.5 x upper limit of normal (ULN) (unless patient had Gilbert's syndrome)\n   6. alanine aminotransferase (ALT) \\\u003C= 2.5 x ULN\n   7. Estimated glomerular filtration rate of at least 50 mL\u002Fmin by Cockcroft Gault Formula\n9. 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 study drug, for the duration of study participation, and for 90-days following completion of the therapy. Should a female participant become pregnant or suspect a pregnancy while participating in this study, the treating physician must be informed immediately. IF a male participant impregnates or is suspected of impregnating a woman while participating in this study, the treating physician must be informed immediately.\n\n   • 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:\n   * Has not undergone a hysterectomy or bilateral oophorectomy or\n   * Has not had \\>= 12 months of non-therapy-induced amenorrhea.\n10. Participants must not be breastfeeding.\n11. 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.\n\nExclusion Criteria:\n\nParticipants may not meet any of the following exclusion criteria to be eligible for study entry:\n\n1. Prior treatment for High Grade Glioma (HGG).\n2. 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 localized prostate carcinoma or cervical carcinoma in situ after curative treatment.\n3. Histological confirmed oligodendroglioma (IDH-mutant and 1p.19q-codeleted) or mixed glioma.\n4. A contrast-enhancing brain tumor that is any of the following:\n\n   1. 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\n   2. Associated with either diffuse subependymal or leptomeningeal dissemination or\n   3. \\> 5cm in any dimension.\n5. Participant has or had an active infection requiring antibiotic, antifungal or antiviral therapy in the 4 weeks preceding study Cycle 1: Day 1.\n6. 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 surgery.\n7. Participant is HIV positive.\n8. 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 Virus (HCV) Antibody and HCV-RNA) or Hepatitis B and C co-infection (positive test for HBsAg or HBcAb and positive test for HCV Antibody).\n9. Participant has a history of allergy or intolerance to flucytosine (DB107-FC).\n10. 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.\n11. Participant intends to undergo treatment with the Gliadel® wafer at the time of resection surgery or has received Gliadel® wafer \\\u003C 30 days from Cycle 1: Day 1.\n12. Severe pulmonary, cardiac or other systemic disease, which as per Investigator assessment would prevent surgical resection.\n13. 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.","ALL","18 Years",{"count":188,"type":189},70,"ESTIMATED","INTERVENTIONAL",[192,193],"PHASE1","PHASE2","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.",[196,197,198],"High Grade Glioma","MGMT-Unmethylated Glioblastoma","MGMT-Methylated Glioblastoma",[200,201],"Gene therapy","Combination therapy","2026-03-09",{"date":204,"type":205},"2026-03-11","ACTUAL",{"date":207,"type":205},"2025-01-08",{"date":209,"type":189},"2042-01-31",{"name":5,"class":6},5]