Dendritic Cell (DC) Vaccine for Malignant Glioma and Glioblastoma

Inclusion Criteria

• •1. Age: ≥ 13 years and ≤ 99 years.
• •2. (2a) Relapse of high grade glioma (anaplastic astrocytoma World Health Organization (WHO) grade III or glioblastoma multiforme WHO grade IV), histologically proven at first stage of disease (radiological evidence for recurrence suffices); OR (2b) Relapse of glioma, which was grade II at initial diagnosis, but which is grade III or IV at relapse based on radiological or pathological criteria.
• •3. Total or subtotal resection of tumor mass, confirmed by assessment by the neurosurgeon and by postoperative MRI scan within 72 hours after surgery. The post-operative assessment should demonstrate residual tumor less than or equal to 2 cm\^3 as judged by surgeon and on MRI the tumor should only show linear contrast enhancement at the border of the resection cavity or nodule less than 2 cm\^3.
• •4. No radiotherapy and/or chemotherapy received for at least 1 month before first DC vaccination is to be administered
• •5. No treatment with corticosteroids or salicylates for at least 1 week before first vaccination. Corticosteroid therapy should be rapidly weaned within 1-2 weeks after surgery.
• •6. Life expectancy \> 3 months.
• •7. Written consent by patient or parent(s) (if patient is \< 18 years) on an institutional review board (IRB)-approved informed consent form prior to any study-specific evaluation. Assent is required from children as per University of Miami (UM) IRB guidelines. Subject must be capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent.
• •8. Adequate organ function (to be measured at enrollment)
• •* Absolute neutrophil count (ANC) ≥ 0.75 10\*3/µl
• •* Lymphocytes ≥ 0.5 10\*3/µl
• •* Platelets ≥ 75 10\*3/µl
• •* Hemoglobin ≥ 9 g/dL
• •* Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤ 2.5 X upper limit of normal (ULN); if liver metastases, ≤ 5 X ULN
• •* Serum Creatinine ≤ 1.5 X ULN
• •* Total Bilirubin ≤ 3 X ULN
• •* Albumin \> 2 g/dL
• •9. Subjects must agree to use adequate method of contraception or abstinence throughout and up to 4 weeks after the study treatment completion.
• •10. Karnofsky score 70 or higher or Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.