[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-malignant-brain-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-malignant-brain-neoplasm":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100586369","phase-1-virus-based-gene-therapy-adv-hsv1-tk-and-adv-flt3l-in-combination-with-valacyclovir-for-the-treatment-of-pediatric-and-young-adult-patients-with-resectable-recurrent-primary-malignant-brain-tumors-100586369",false,"NCT06914479","Virus-Based Gene Therapy (AdV-HSV1-TK and AdV-Flt3L) in Combination With Valacyclovir for the Treatment of Pediatric and Young Adult Patients With Resectable, Recurrent Primary Malignant Brain Tumors","A Phase 1 Study of a Combined Cytotoxic and Immune-Stimulatory Therapy in Pediatric and Young Adult Patients With Recurrent, Primary Malignant Brain Tumors","Inclusion Criteria:\n\n* Age 3 to 25 years with:\n\n  * Diagnosis of malignant primary brain tumor after tumor recurrence, relapse, or progression who have completed up-front, standard-of-care therapy\n* Age 26 to 39 years with:\n\n  * Diagnosis of diffuse hemispheric glioma, H3 G34-mutant, per 2021 World Health Organization (WHO) classification, after tumor recurrence, relapse, or progression who have completed up-front, standard-of-care therapy\n* At least 10 kg (and body surface area \\[BSA\\] \\> 0.5 m\\^2)\n* Participants who are receiving corticosteroids must be on a stable or decreasing dose for at least 3 days prior to baseline MRI\n* Surgical resection of the tumor recurrence\u002Frelapse\u002Fprogression is clinically indicated at the time of enrollment\n* A legal parent\u002Fguardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate\n* Participant must be willing to provide archival formalin-fixed embedded (FFPE) and\u002For frozen tissue specimens, if available\n* Participant must have recovered from all acute side effects of prior therapy.\n\n  * From the projected start of scheduled study treatment, the following time periods must have elapsed: At least 7 days after last dose of a biologic agent or beyond time during which adverse events are known to occur for a biologic agent, 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibody therapy (21 days for bevacizumab,.6 weeks from cellular therapy (i.e. modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.), or 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies\n* For participants who have received radiotherapy previously, participants must be at least 28 days from focal radiation therapy, at least 150 days from craniospinal irradiation therapy.\n\n  * The use of bevacizumab to control radiation therapy-induced edema is allowed prior to or during study therapy (if used for tumor-directed therapy, please see required washout period above).\n\n    * Dosing limitations are as follows:\n\n      * Bevacizumab (or bioequivalent) for up to a maximum of 5 doses, dosing per institutional standard. There is no required washout period\n* Prior use of temozolomide during radiation at maximum of the standard pediatric dosing (defined as 90 mg\u002Fm\\^2\u002Fdose continuously during radiation therapy) or dexamethasone is allowed\n* Peripheral absolute neutrophil count (ANC) ≥ 1000\u002Fmm\\^3 (1.0g\u002Fl)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (100x10\\^9\u002Fl) (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70mL\u002Fmin\u002F1.73 m\\^2 or a serum creatinine within the normal limits for age\n* Bilirubin (sum of conjugated + unconjugated) ≤ 2 x upper limit of normal (ULN) for age\n* Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x ULN\n* Serum albumin ≥ 2 g\u002FdL\n* Performance score ≥ 60 (Karnofsky for participants \\> 16 years of age, Lansky for participants ≤ 16 years of age.)\n\n  * Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score\n* The effects of the study drugs on the developing human fetus are unknown. For this reason, females of child-bearing potential (FOCBP) and males must agree to use adequate contraception for the duration of study participation and 30 days after last dose of AdV-HSV1-TK\u002FAdV-Flt3L or valacyclovir, whichever is later.\n\n  * Adequate methods include hormonal or barrier method of birth control, or abstinence at the time of study entry and for the duration of study participation.\n  * Should a participant become pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately.\n  * Males treated on this study must also agree to use adequate contraception as of the time of enrollment onto the study and for the duration of study participation. Male participants must notify the treating physician immediately if his partner becomes pregnant while he is receiving study therapy\n\nExclusion Criteria:\n\n* Patient deemed not clinically appropriate to undergo tumor tissue resection by a neurosurgeon\n* Evidence of disseminated disease, including diffuse leptomeningeal disease or evidence of cerebrospinal fluid (CSF) dissemination\n* Patient with primary brainstem or primary spinal tumors\n* History of prior gene therapy\n* Ongoing therapy with valacyclovir that is unable to be stopped due to a medical condition\n* Known allergy to valacyclovir\n* Concurrent use of other investigational agents.\n\n  * Participants who are currently receiving another investigational drug. Investigational imaging agents or agents used to enhance tumor visibility on imaging or during tumor biopsy\u002Fresection should be discussed with the study chairs\n* Participants who are currently receiving anti-cancer agents\n* Participants with a known disorder that affects their immune system, such as HIV or hepatitis B or C, or an auto-immune disorder requiring systemic cytotoxic or immunosuppressive therapy\n* Presence of uncontrolled infection or other uncontrolled systemic illness\n* Current diagnosis of bipolar disorder or major depressive disorder\n* Presence of a congenital immune deficiency syndrome or acquired autoimmune disease\n* Female participants of childbearing potential must not be pregnant or breast-feeding. Female participants of childbearing potential must have a negative serum or urine or serum pregnancy test prior to the start of therapy (as clinically indicated)\n* Active illicit drug use or diagnosis of alcoholism\n* History of kidney transplant\n* History of allogeneic stem cell transplantation\n* Known additional malignancy that is progressing or requires active treatment within 3 years of start of study drug","ALL","3 Years","39 Years",{"count":20,"type":21},11,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This phase I trial tests the safety, side effects and best dose of AdV-HSV1-TK and AdV-Flt3L in combination with valacyclovir for the treatment of patients with primary cancerous (malignant) brain tumors that can be removed by surgery (resectable) and that have come back after a period of improvement (recurrent). AdV-HSV1-TK and AdV-Flt3L use a virus modified in the laboratory to kill tumor cells and stimulate the immune system to recognize the tumor cells as \"invaders\" which can lead to tumor shrinkage. For this process to work, an oral anti-herpes medication called valacyclovir is also needed. Giving AdV-HSV1-TK, AdV-Flt3L and valacyclovir may be safe, tolerable and\u002For effective in treating patients with resectable, recurrent primary malignant brain tumors.",[27,28,29],"Recurrent Diffuse Hemispheric Glioma, H3 G34-Mutant","Recurrent Malignant Brain Neoplasm","Resectable Brain Neoplasm","RECRUITING","2026-06-11",{"date":33,"type":34},"2026-06-15","ACTUAL",{"date":36,"type":34},"2026-05-22",{"date":38,"type":21},"2031-05",{"name":40,"class":41},"University of Michigan Rogel Cancer Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100401653","phase-1-car-t-cells-after-lymphodepletion-for-the-treatment-of-il13r2-positive-recurrent-or-refractory-brain-tumors-in-children-100401653","NCT04510051","CAR T Cells After Lymphodepletion for the Treatment of IL13Rα2 Positive Recurrent or Refractory Brain Tumors in Children","Phase I Study of Cellular Immunotherapy Using Memory Enriched T Cells Lentivirally Transduced to Express an IL13Rα2-Targeting, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Children With Recurrent\u002FRefractory Malignant Brain Tumors","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n* Karnofsky Performance Status (KPS) \\>= 60% except for loss of mobility due to disease involvement; e.g., confinement to a wheelchair due to spinal cord compression\n* Life expectancy \\> 4 weeks\n* Participant has a prior histologically-confirmed malignant brain neoplasm and has progressed after prior conventional therapy\n* Radiographic evidence of progression\u002Frecurrence of the measurable disease more than 12 weeks after the end of the initial conventional therapy (including initial radiation therapy)\n* City of Hope (COH) clinical pathology confirms IL13Ralpha2+ tumor expression by immunohistochemistry (IHC) at the initial tumor presentation or recurrent disease (H-score \\>= 50)\n* If the participant has a shunt, it must be programmable and the participant must be able to tolerate the shunt being switched off for at least 2 consecutive days\n* Platelets \\>= 50,000\u002Fmm\\^3 (performed within 6 weeks of signing the main informed consent)\n* Total bilirubin =\\\u003C 2 X upper limit of normal (ULN) (unless has Gilbert's disease) (performed within 6 weeks of signing the main informed consent)\n* Aspartate transaminase (AST) =\\\u003C 2 x ULN (performed within 6 weeks of signing the main informed consent)\n* Alanine transferase (ALT) =\\\u003C 2 x ULN (performed within 6 weeks of signing the main informed consent)\n* Creatinine clearance of \\>= 75mL\u002Fmin\u002F1.73m\\^2 (performed within 6 weeks of signing the main informed consent)\n* Seronegative for human immunodeficiency virus (HIV) antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV)\\* and active HBV (surface antigen negative) (performed within 6 weeks of signing the main informed consent)\n\n  * If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (to be performed within 6 weeks of signing the main informed consent)\n* Agreement by females and males of childbearing potential\\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (males and females) or have not been free, once initiated, from menses for \\> 1 year (females only)\n* ELIGIBILITY TO PROCEED WITH PERIPHERAL BLOOD MONONUCLEAR COLLECTION (PBMC) COLLECTION\n* Research participant must not require more than 0.1mg\u002Fkg\u002Fday total dose (0.03mg\u002Fkg\u002Fdose three times per day, max of 6mg\u002Fday) of Dexamethasone on the day of peripheral blood mononuclear cell (PBMC) collection\n* Research participant must have appropriate venous access\n* At least 2 weeks must have elapsed since the research participant received his\u002Fher last dose of prior targeted agents, chemotherapy or radiation\n* Note: If a research participant weighs less than 50kgs, the study team should provide the Donor Apheresis Center (DAC) with the participant's current weight so that institutional guidelines can be followed\n* ELIGIBILITY TO PROCEED WITH INDWELLING CENTRAL NERVOUS SYSTEM (CNS) CATHETER PLACEMENT\n* Serum creatinine \\\u003C 1.6 mg\u002FdL\n* White blood cell (WBC) \\>= 2,000\u002FdL\n* Absolute neutrophil count (ANC) \\>= 1,000\n* Platelets \\> 50,000\u002FdL\n* International normalized ratio =\\\u003C 1.3\n* Bilirubin \\\u003C 1.5 mg\u002FdL\n* Alanine transferase (ALT) and aspartate transaminase (AST) \\\u003C 2 x upper limits of normal\n* KPS \\>= 60% except for loss of mobility due to disease involvement; e.g., confinement to a wheelchair due to spinal cord compression\n* Second-line radiation therapy (post-leukapheresis) completed at least 4 weeks prior to surgical resection or biopsy\u002Fcatheter placement\n* ELIGIBILITY TO PROCEED WITH LYMPHODEPLETION\n* Pulmonary: Research participant does not require supplemental oxygen to keep saturation greater than 95% and\u002For does not have presence of any radiographic abnormalities on chest x-ray that are progressive\n* Cardiac: Research participant does not require pressor support and\u002For does not have symptomatic cardiac arrhythmias\n* Active infection: Research participant does not have a fever exceeding 38.5 degree celsius; there is an absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to CAR T cell infusion and\u002For there aren't any indications of meningitis\n* Hepatic: Research participant serum total bilirubin or transaminases does not exceed 2 x normal limit\n* Renal: Research participant serum creatinine \\\u003C 1.8 mg\u002FdL\n* Neurologic: Research participant does not have uncontrolled seizure activity following surgery prior to starting lymphodepletion\n* ELIGIBILITY TO PROCEED WITH EACH CAR T CELL INFUSION\n* Research participant has a released cryopreserved T cell product\n* Research participant does not require supplemental oxygen to keep saturation greater than 95% and\u002For does not have presence of any radiographic abnormalities on chest x-ray that are progressive\n* Research participant does not require pressor support and\u002For does not have symptomatic cardiac arrhythmias\n* Research participant does not have a fever exceeding 38.5 degree celsius; there is an absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to T cell infusion and\u002For there aren't any indications of meningitis\n* Research participant serum total bilirubin or transaminases does not exceed 2 x normal limit\n* Research participant serum creatinine \\\u003C 1.8 mg\u002FdL\n* Research participant does not have uncontrolled seizure activity\n* Research participant platelet count must be \\>= 50,000. However, if platelet level is between 25,000-49,000, then T-cell infusion may proceed after platelet transfusion is given and the post transfusion platelet count is \\>= 50,000\n* Research participants must not require more than 0.1mg\u002Fkg\u002Fday total dose (0.03mg\u002Fkg\u002Fdose three times per day, max of 6mg\u002Fday) of dexamethasone during CAR T cell therapy\n* Wash-out requirements:\n\n  * At least 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen;\n  * At least 23 days since the completion of temozolomide and\u002For 4 weeks for any other non-nitrosourea-containing cytotoxic chemotherapy regimen. If a patient's most recent treatment was with a targeted agent only, and s\u002Fhe has recovered from any toxicity of this targeted agent, then a waiting period of only 2 weeks is needed from the last dose\n  * For bevacizumab the wash out period of at least 4 weeks is required before starting study treatment\n\nExclusion Criteria:\n\n* Pulmonary: Research participant requires supplemental oxygen to keep saturation greater than 95% and the situation is not expected to resolve within 2 weeks\n* Cardiac: Research participant requires pressor support and\u002For has symptomatic cardiac arrhythmias\n* Renal: Research participant requires dialysis\n* Neurologic: Research participant has uncontrolled seizure activity and\u002For clinically evident progressive encephalopathy\n* Failure of research participant to understand the basic elements of the protocol and\u002For the risks\u002Fbenefits of participating in this phase I study. A legal guardian may substitute for the research participant\n* Research participant with any non-malignant intercurrent illness which is either poorly controlled with currently available treatment, or which is of such severity that the study team deems it unwise to enter the research participant on protocol shall be ineligible\n* Research participant with any other active malignancies\n* Research participant being treated for severe infection or recovering from major surgery is ineligible until recovery is deemed complete by the study team\n* Research participant with any uncontrolled illness including ongoing or active infection. Research participant with known active hepatitis B or C infection; research participant with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections\n* Research participant who has confirmed HIV positivity within 4 weeks of enrollment\n* Females only: Pregnant or breastfeeding\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","4 Years","25 Years",{"count":53,"type":21},18,[24],"This phase I trial investigates the side effects of chemotherapy and cellular immunotherapy in treating children with IL13Ralpha2 positive brain tumors that have come back after a period of improvement (recurrent) or do not respond to treatment (refractory). Cellular immunotherapy (IL13(EQ)BBzeta\u002FCD19t+ T cells) are brain-tumor specific cells that may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Many patients with brain tumor respond to treatment, but then the tumor starts to grow again. Giving chemotherapy in combination with cellular immunotherapy may kill more tumor cells and improve the outcome of treatment.",[57,28,58],"Malignant Brain Neoplasm","Refractory Malignant Brain Neoplasm","2026-03-03",{"date":61,"type":34},"2026-03-05",{"date":63,"type":34},"2020-12-04",{"date":65,"type":21},"2027-02-24",{"name":67,"class":41},"City of Hope Medical Center",3]