Vaccine Therapy in Treating Young Patients Who Are Undergoing Surgery for Malignant Glioma
Brain and Central Nervous System Tumors
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring childhood high-grade cerebral astrocytoma, recurrent childhood cerebral astrocytoma, childhood oligodendroglioma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed* WHO grade III or IV malignant glioma of 1 of the following subtypes: Anaplastic astrocytoma Anaplastic oligodendroglioma Glioblastoma multiforme NOTE: *Must be confirmed after surgery Newly diagnosed OR recurrent disease Bidimensionally measurable disease by contrast-enhancing pre-operative MRI Surgically accessible tumor for which surgical resection is indicated at the time of initial pre-operative evaluation Must have undergone standard surgery* AND either radiotherapy* or chemoradiotherapy* Objective evidence of disease by contrast-enhanced brain MRI after completion of standard therapy NOTE: *Completed after study entry but before assignment to study treatment cohorts Age 1 to 18 Performance status Karnofsky 60-100% Hematopoietic Hemoglobin ≥ 10 g/dL Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic SGPT and SGOT ≤ 2 times normal Alkaline phosphatase ≤ 2 times normal Bilirubin ≤ 1.5 mg/dL Hepatitis B and C negative Renal BUN ≤ 1.5 times normal OR Creatinine ≤ 1.5 times normal Immunologic HIV negative Syphilis negative At least 2 weeks since prior radiotherapy and recovered Negative pregnancy test Fertile patients must use effective contraception More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No chemotherapy during and for 4 weeks* after the final dose of study vaccine No corticosteroids for at least 10 days before leukapheresis No concurrent corticosteroids More than 72 hours since prior systemic antibiotics No antihistamines for 5 days before and for 5 days after administration of study vaccine Exclusion Criteria: history of immunodeficiency or autoimmune disease that may be exacerbated by immunotherapy, including any of the following: Rheumatoid arthritis Systemic lupus erythematosus Vasculitis Polymyositis Dermatomyositis Scleroderma Multiple sclerosis Juvenile-onset insulin-dependent diabetes active infection fever allergy to study reagents pregnant or nursing other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, localized prostate cancer, or carcinoma in situ of the cervix unstable or severe medical or psychiatric condition, as determined by the investigator underlying condition that would preclude study participation concurrent radiotherapy prior organ allograft concurrent strong painkillers other concurrent immune-suppressing medications other concurrent investigational agents other adjuvant treatment for 4 weeks* after the final dose of study vaccine NOTE: *Unless there is evidence of tumor progression necessitating additional clinically-indicated treatment; patients requiring treatment due to tumor progression are removed from the study
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA
Arms of the Study
Arm 1
Experimental
Vaccine