Cytomegalovirus (CMV) RNA-Pulsed Dendritic Cells for Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma

1. Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible)

2. Disease outside of the central nervous system (CNS)

3. Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C seropositive

4. Known active infection requiring intravenous (IV) antibiotics or active immunosuppressive disease

5. Severe, active co-morbidity, defined as follows:

1. Unstable angina and/or congestive heart failure requiring hospitalization

2. Transmural myocardial infarction within the last 6 months

3. Acute bacterial or fungal infection requiring intravenous antibiotics at initiation of Radiation Therapy (XRT)/Temozolomide (TMZ)

4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at initiation of XRT/TMZ for newly diagnosed patients or at initiation of dose-intensified (DI) TMZ for recurrent patients

5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

6. Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive

7. Patients with autoimmune disease requiring medical management with immunosuppressant(s)

8. Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy

9. Active connective tissue disorders such as lupus or scleroderma that, in the investigator's opinion, place the patient at high risk for radiation toxicity

6. Pregnant or lactating women

7. Prior allergy to TMZ, GM-CSF, gadolinium (Gd), or Td

8. Prior history of brachial neuritis or Guillain-Barré syndrome

9. Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry

10. Patients receiving \> 0.1mg/kg or 4mg/day dexamethasone or equivalent

10\. For recurrent patients only: Patients who have not recovered from the toxic effects of prior chemo- and/or radiation therapy. Guidelines for this recovery period are dependent upon the specific therapeutic agent being used:

1. Patients who have received chemotherapy or bevacizumab ≤ 4 weeks \[except for nitrosourea (6 weeks) or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)\] prior to starting the study drug unless patients have recovered from the side effects of such therapy. If the patient was receiving bevacizumab at the time of enrollment, the treating oncologist has the discretion of administering and adjusting bevacizumab 10 mg/kg every 14 days.

2. Patients who have received immunotherapy ≤ 4 weeks prior to starting the study drug unless patients have recovered from the side effects of such therapy

What this study is about