Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors

Inclusion Criteria:

- Age: > or equal to 1 year and < 30 years

- Relapse or progression of any central nervous system tumor initially diagnosed before
the age of 21 years.

- 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
cm3 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 cm3.

- No radiotherapy and/or chemotherapy received for at least 1 month before first DC
vaccination is to be administered

- No treatment with corticosteroids or salicylates for at least 1 week before first
vaccination.

- Life expectancy > 3 months

- 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 UM IRB guidelines.

- Adequate organ function (to be measured at enrollment):

- Absolute neutrophil count (ANC) >750/L

- Lymphocytes > 500/L

- Platelets > 75,000/L

- Hemoglobin > 9 g/dL

- AST/ALT < 2.5 X ULN; if liver metastases, < 5 X ULN

- Serum Creatinine < 1.5 X ULN

- Total Bilirubin < 3 X ULN

- Albumin > 2 g/dL

- Subjects must agree to use adequate method of contraception or abstinence throughout
and up to 4 weeks after the study treatment completion.

- Capable of understanding the investigational nature, potential risks and benefits of
the study and able to provide valid informed consent.

- Karnofsky score greater than or equal to 70 or ECOG status of 0 or 1.

Exclusion Criteria:

- Pregnancy

- Breast feeding females

- Any concomitant participation in other therapeutic trials

- Virus serology positive for HIV (testing is not required in the absence of clinical
suspicion)

- Documented immunodeficiency

- Documented autoimmune disease

- Other active malignancies

- Refusal to use adequate contraception for fertile patients (females and males) during
the study and for 30 days after the last dose of study treatment.

- Any serious or uncontrolled medical or psychiatric condition that in the opinion of
the investigator makes the patient not able to participate in the study.

- Application of gliadel wafers within the prior 4 months or a plan to place gliadel
wafers at the time of resection for tumor acquisition for study