[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100236609":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":50,"collaborators":54,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":20,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":20,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":20,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC","EXPERIMENTAL","All subjects will receive vaccine plus Poly-ICLC. Injections will be given every 3 week for a total of 8 vaccines.",[13],"Biological: Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC","Poly-ICLC is administered intramuscularly (i.m.) using sterile technique, as supplied from the vial, and in the amount prescribed for the participant's weight. Patients should receive a dose of acetaminophen (15 mg\u002Fkg up to a max of 1000 mg) 30-60 minutes before each poly-ICLC administration. The poly-ICLC treatments will be administered immediately following the vaccine. Patients\u002Fparents will be asked to report any temperature elevations and side effects after each treatment.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"James Felker, MD","PRINCIPAL_INVESTIGATOR",[26,29],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},"CONTACT","412 692-5055",{"name":30,"role":27,"phone":31,"phoneExt":20,"email":32},"Sharon Dibridge","412-692-7070","sharon.dibridge@chp.edu",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Children's Hospital of Pittsburgh of UPMC","RECRUITING","Pittsburgh","Pennsylvania","15224","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-79.99589,40.44062,{"lat":46,"lon":45},[49],{"name":30,"role":27,"phone":31,"phoneExt":20,"email":32},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","James Felker","Assistant Professor",[55,57],{"name":56,"class":6},"Connor's Cure",{"name":58,"class":59},"National Cancer Institute (NCI)","NIH","100236609","phase-2-a-vaccine-trial-for-low-grade-gliomas-100236609",false,"NCT02358187","A Vaccine Trial for Low Grade Gliomas","A Phase II Study of Vaccinations With HLA-A2 Restricted Glioma Antigen Peptides in Combination With Poly-ICLC for Children With Recurrent Unresectable Low-Grade Gliomas (LGG)","Inclusion Criteria:\n\nTumor Type\n\n* Unresectable low-grade gliomas that have received at least two chemotherapy\u002Fbiologic regimens. Radiation therapy counts as a biologic regimen. Patients may not have received radiation therapy to the index lesion within 1 year of enrollment. Patients may have tumor spread within the central nervous system (CNS).\n* HLA-A2 positive based on flow cytometry.\n* Patients must be clinically stable and off or on low-dose (no more than 0.1 mg\u002Fkg\u002Fday, max 4 mg\u002Fday Dexamethasone) corticosteroid for at least one week prior to study registration.\n* Patients must be ≥ 12 months and \\\u003C 22 years of age at the time of HLA-A2 screening.\n* Patients must have a performance status of ≥ 70; (Karnofsky if \\> 16 years and Lansky if ≤ 16 years of age.\n* Documented negative serum beta-human chorionic gonadotropin (HCG) for female patients who are post-menarchal. Because the effect of the peptide-based vaccine and poly-ICLC on the fetus has not sufficiently been investigated, pregnant females will not be included in the study.\n* Patients must be free of systemic infection requiring IV antibiotics at the time of registration. Patients must be off IV antibiotics for at least 7 days prior to registration.\n* Patients with adequate organ function as measured by: Bone marrow: absolute neutrophil count (ANC) \\> 1,000\u002Fµ; Platelets \\> 100,000\u002Fµ (transfusion independent); absolute lymphocyte count of ≥ 500\u002Fµ; Hemoglobin \\>8 g\u002Fdl (may be transfused). Hepatic: bilirubin \\\u003C 1.5x institutional normal for age; serum glutamate pyruvate transaminase (SGPT) \\\u003C 3x institutional normal.\n* Renal: Serum creatinine based on age or Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 ml\u002Fmin\u002Fml\u002Fmin\u002F1.73 m²\n* Patients must have recovered from the toxic effects of prior therapy to grade 1 or better. Patients must be at least 3 weeks from the last dose of standard cytotoxic chemotherapy or myelosuppressive biological therapy and at least 1 week from the last dose of non-myelosuppressive biologic therapy.\n* No overt cardiac, gastrointestinal, pulmonary or psychiatric disease.\n\nExclusion Criteria:\n\n* Patients living outside of North America are not eligible.\n* Patients may not have received radiation to the index lesion within 1 year of enrollment.\n* Concurrent treatment or medications (must be off for at least 1 week) including:\n\n  * Interferon (e.g. Intron-A®)\n  * Allergy desensitization injections\n  * Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)\n  * Interleukins (e.g. Proleukin®)\n  * Any investigational therapeutic medication\n* Patients must not have a history of, or currently active autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement.\n* Use of immunosuppressives within four weeks prior to study entry or anticipated use of immunosuppressive agents. Dexamethasone, or other corticosteroid medications, if used in the peri-operative period must be tapered to no more than 0.1 mg\u002Fkg\u002Fday, max 4 mg\u002Fday dexamethasone for at least one week before study registration. Topical corticosteroids are acceptable.\n* Because patients with immune deficiency are not expected to respond to this therapy, HIV-positive patients are excluded from the study.\n* Patients who have received prior immunotherapy.","ALL","12 Months","21 Years",{"count":71,"type":72},25,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","The study will assess the immunogenicity, safety and preliminary clinical efficacy of the glioma associated antigen (GAA)\u002Ftetanus toxoid (TT) peptide vaccine and poly-ICLC in HLA-A2+ children with unresectable low-grade gliomas that have received at least two chemotherapy\u002Fbiologic regimens. Radiation therapy counts as one biologic regimen, but patients may not have received radiation to the index lesion within 1 year of enrollment.",[78],"Low Grade Glioma","2026-01-05",{"date":81,"type":82},"2026-01-07","ACTUAL",{"date":84,"type":20},"2015-01",{"date":86,"type":72},"2028-12-31",{"name":52,"class":6},1]