[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05956821":3,"trial-entities:NCT05956821":115,"trial-summary:NCT05956821":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":27,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":33,"interventions":36,"primary_outcomes":45,"secondary_outcomes":61,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":15,"eligibility_criteria":65,"std_ages":84,"locations":87,"central_contacts":105,"overall_officials":107,"references":109,"see_also_links":114},"NCT05956821","20230032","Treatment of Relapsed\u002FRefractory Intracranial Glioma in Patients Under 22 Years of Age","Phase I\u002FII Trial of Repeat Dosing of Super-Selective Intraarterial Infusion of Erbitux (Cetuximab) and Avastin (Bevacizumab) for Treatment of Relapsed\u002FRefractory Intracranial Glioma in Patients Under 22 Years of Age","RECRUITING","2029-12-01","2025-12","2025-12-08","2025-06-19","University of Miami","OTHER",true,"This study assesses the safety and efficacy of repeat monthly dosing of super-selective intra-arterial cerebral infusion (SIACI) of cetuximab and bevacizumab in patients \\\u003C 22 years of age.",null,[19,20,21,22,23,24,25,26],"Glioblastoma Multiforme","Anaplastic Astrocytoma","Fibrillary Astrocytomas","Oligodendroglioma","Diffuse Intrinsic Brainstem Glioma","Diffuse Intrinsic Pontine Glioma","DIPG Brain Tumor","H3 K27M",[],"INTERVENTIONAL","TREATMENT",[31,32],"PHASE1","PHASE2",{"count":34,"type":35},20,"ESTIMATED",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","SIACI of cetuximab and bevacizumab","Subjects will receive monthly dosing of bevacizumab (15 mg\u002Fkg) and cetuximab (200mg\u002Fm2)",[39],[43,44],"erbitux","avastin",[46,50,54,58],{"measure":47,"description":48,"timeFrame":49},"Number of Treatment Related Adverse Events","The number of treatment-related adverse events will be assessed and graded according to the NCI Common Toxicity Criteria, version 5.0.","1 month post injection",{"measure":51,"description":52,"timeFrame":53},"Composite Overall Response Rate (CORR)","The overall response proportion along with a 95% confidence interval will be estimated via binomial proportions. We will define \"evaluable\" patients as patients who met eligibility requirements and have initiated therapy.","6 months",{"measure":55,"description":56,"timeFrame":57},"Progression-free survival (PFS)","PFS will be measured from the date of the first dose of SIACI Cetuximab\u002FAvastin to the date of progression.","1 year",{"measure":59,"description":60,"timeFrame":57},"Overall Survival (OS)","OS will be measured from the date of diagnosis to the date of death",[],"ALL","1 Year","21 Years",{"inclusion":66,"exclusion":79,"raw_text":83},[67,68,69,70,71,72,73,74,75,76,77,78],"Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), fibrillary astrocytomas (FA), pilomyxoid astrocytoma (PXA), oligodendroglioma, or anaplastic mixed oligoastrocytoma (AOA), or radiologically diagnosed diffuse intrinsic brainstem glioma (DIPG)","Must have at least one confirmed and evaluable tumor site","Must have a Karnofsky or Lansky performance status ≥60%.","No chemotherapy for three weeks prior to treatment","Patients must have adequate hematologic reserve with absolute neutrophils≥1000\u002Fmm3 and platelets ≥100,000\u002F mm3","Pre-enrollment chemistry parameters must show: bilirubin\\\u003C1.5x the institutional upper limit of normal (IUNL); Aspartate Aminotransferase( AST) or Alanine transaminase (ALT)\\\u003C2.5x IUNL and creatinine\\\u003C1.5x IUNL","Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5x the IUNL","Growth factor(s): Must not have received within 1 week of entry onto this study","Steroids: Systemic corticosteroid therapy is permissible in patients with Central Nervous System (CNS) tumors for treatment of increased intracranial pressure or symptomatic tumor edema. Patients with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to study entry.","Patients of reproductive age must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study","Patients or their parents\u002Fguardians must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening","Because of known concerns with Avastin and wound healing, craniotomy patients are eligible for the treatment if they have had a craniotomy greater than two weeks prior to Intra-Arterial (IA) therapy. Craniotomy or major procedure after SIACI Avastin therapy should wait 4 weeks. Minor surgeries may be performed after two weeks",[80,81,82],"Females who are pregnant or lactating","Females of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period. If they do not agree, they will be ineligible for the study","Patients with significant concurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring","Inclusion Criteria:\n\n* Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), fibrillary astrocytomas (FA), pilomyxoid astrocytoma (PXA), oligodendroglioma, or anaplastic mixed oligoastrocytoma (AOA), or radiologically diagnosed diffuse intrinsic brainstem glioma (DIPG)\n* Must have at least one confirmed and evaluable tumor site\n* Must have a Karnofsky or Lansky performance status ≥60%.\n* No chemotherapy for three weeks prior to treatment\n* Patients must have adequate hematologic reserve with absolute neutrophils≥1000\u002Fmm3 and platelets ≥100,000\u002F mm3\n* Pre-enrollment chemistry parameters must show: bilirubin\\\u003C1.5x the institutional upper limit of normal (IUNL); Aspartate Aminotransferase( AST) or Alanine transaminase (ALT)\\\u003C2.5x IUNL and creatinine\\\u003C1.5x IUNL\n* Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5x the IUNL\n* Growth factor(s): Must not have received within 1 week of entry onto this study\n* Steroids: Systemic corticosteroid therapy is permissible in patients with Central Nervous System (CNS) tumors for treatment of increased intracranial pressure or symptomatic tumor edema. Patients with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to study entry.\n* Patients of reproductive age must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study\n* Patients or their parents\u002Fguardians must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening\n* Because of known concerns with Avastin and wound healing, craniotomy patients are eligible for the treatment if they have had a craniotomy greater than two weeks prior to Intra-Arterial (IA) therapy. Craniotomy or major procedure after SIACI Avastin therapy should wait 4 weeks. Minor surgeries may be performed after two weeks\n\nExclusion Criteria:\n\n* Females who are pregnant or lactating\n* Females of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period. If they do not agree, they will be ineligible for the study\n* Patients with significant concurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring",[85,86],"CHILD","ADULT",[88],{"facility":89,"status":8,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":102},"Jackson Memorial Hospital","Miami","Florida","33136","United States",[95,100],{"name":96,"role":97,"phone":98,"email":99},"Heather McCrea, MD","CONTACT","305-585-3627","hmccrea@med.miami.edu",{"name":96,"role":101},"PRINCIPAL_INVESTIGATOR",{"lat":103,"lon":104},25.77427,-80.19366,[106],{"name":96,"role":97,"phone":98,"email":99},[108],{"name":96,"affiliation":13,"role":101},[110],{"pmid":111,"type":112,"citation":113},"34359048","BACKGROUND","McCrea HJ, Ivanidze J, O'Connor A, Hersh EH, Boockvar JA, Gobin YP, Knopman J, Greenfield JP. Intraarterial delivery of bevacizumab and cetuximab utilizing blood-brain barrier disruption in children with high-grade glioma and diffuse intrinsic pontine glioma: results of a phase I trial. J Neurosurg Pediatr. 2021 Aug 6;28(4):371-379. doi: 10.3171\u002F2021.3.PEDS20738. Print 2021 Oct 1.",[],{"nct_id":4,"conditions":116,"biomarkers":121},[20,24,117,118,119,22,120],"Fibrillary Astrocytoma","Glioblastoma","Mouse Anaplastic Oligoastrocytoma","Pilomyxoid Astrocytoma",[122],"H3 K27M Variant",{"nct_id":4,"found":15,"summary":124,"prompt_version":134},{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.","completed","Study of Cetuximab and Bevacizumab for Relapsed\u002FRefractory Glioma in Patients Under 22","This study is looking at a treatment for children and young adults (ages 1 to 21) with certain types of brain tumors (glioma) that have come back or haven't responded to previous treatments. It's testing the safety and effectiveness of giving two drugs, cetuximab and bevacizumab, directly into the brain's arteries each month. Researchers will be watching for any side effects and how well the tumors respond to the treatment. They also want to see how long patients live without their disease getting worse. The study aims to enroll 20 participants, but its current recruitment status is unclear.","The study measures outcomes up to 1 year after treatment.",98,"Participants will receive monthly doses of bevacizumab and cetuximab. The study will measure side effects at 1 month, tumor response at 6 months, and progression-free survival at 1 year.","Not stated in the trial record.",[],"v2"]