Clinical Research Directory

Screening Eligibility: * Patients with histologically confirmed WHO Grade III or IV malignant glioma * Scheduled for definitive surgical resection of suspected HGG (biopsy only subjects are not eligible for this study) Post-Surgical Resection Eligibility * Histologically confirmed WHO Grade III or IV malignant glioma * Karnofsky Performance Status (KPS) of ≥ 60% (KPS for ≥ 16 years of age) or Lansky performance Score (LPS) of ≥ 60 (LPS for \< 16 years of age) assessed within 2 weeks prior to registration * Bone Marrow: ANC (Absolute neutrophil count) ≥ 1000/µl (unsupported); Platelets ≥ 100,000/µl (unsupported for at least 3 days); Hemoglobin \> 8 g/dL (may be supported) * Renal:Serum creatinine ≤ upper limit of institutional normal * Hepatic: Bilirubin ≤ 1.5 times upper limit of institutional normal for age. SGPT (ALT) ≤ 3 times upper limit of institutional normal for age. SGOT (AST) ≤ 3 times upper limit of institutional normal for age. * Signed informed consent according to institutional guidelines. * Patient or patient guardian consent to PBSC harvest following registration. * Subjects of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control while being treated on this study. * Subjects with post-surgical neurological deficits should have deficits that are stable for a minimum of 1 week prior to leukapheresis. Exclusion Criteria: * Pregnant or need to breast feed during the study period (Negative serum pregnancy test required). * Known autoimmune or immunosuppressive disease or human immunodeficiency virus infection. * Subjects with significant renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), pulmonary, hepatic or other organ dysfunction. * Severe or unstable concurrent medical conditions. * Prior allergic reaction to TMZ, GM-CSF, or Td * Subjects who are unwilling or unable to receive treatment and undergo follow-up evaluations at the enrolled Sunshine Project Consortium treatment site.