Experimental immune therapy for childhood brain cancer shows early safety signals

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.