Vaccine Therapy in Treating Young Patients Who Are Undergoing Surgery for Malignant Glioma

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