A Phase II Feasibility Study of Adjuvant Intra-Nodal Autologous Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme

Inclusion Criteria:

- Histologically proven GBM with central pathology review at Dartmouth-Hitchcock
Medical Center (DHMC)

- Tumor specimen obtained at the time of surgery adequate for vaccination

- 18 years of age or older

- Karnofsky Performance Status 60% or greater

- Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10 9th/L

- Platelets greater than or equal to 100 x 10 9th/L

- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) less than or equal
to 5 times the upper limits of normal (ULN)

- Total bilirubin less than or equal to 1.5 times ULN

- Serum creatinine less than or equal to 1.5 times ULN, OR estimated creatinine
clearance greater than or equal to 60 mL/min

- No known immunosuppression other than chemo-related

- Negative HIV serologies

- No evidence of acute or chronic hepatitis on standard hepatitis C and B screening
tests

- No chemotherapy within four weeks prior to leukapheresis

- Radiotherapy at outside institution is permitted if tissue was obtained at time of
surgery at DHMC and patient is willing to follow-up per protocol

- Off steroids for at least two weeks before leukapheresis

- No second malignancies except non-melanoma skin cancer, and non-invasive cancer such
at cervical CIS, superficial bladder cancer or breast CIS

- Negative serum or urine pregnancy test for women of childbearing potential

- No serious uncontrolled medical disorder or active infection

- All patients must give informed consent

- No history of clinical evidence of active autoimmune disease

Exclusion Criteria:

- Invasive cancers in the past 5 years

- Rheumatologic/autoimmune disease

- Pregnancy or unwillingness to remain on acceptable form of birth control during study

- Major cardiac, pulmonary, or other systemic disease; viral hepatitis; HIV infection