[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"James Felker\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"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":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Low Grade Glioma","RECRUITING","2026-01-05",{"date":31,"type":32},"2026-01-07","ACTUAL",{"date":34,"type":4},"2015-01",{"date":36,"type":21},"2028-12-31",{"name":38,"class":39},"James Felker","OTHER",""]