ACTION Trial- Adoptive Cellular Therapy following Dose-Intensified Temozolomide in Newly-diagnosed Pediatric High-grade Gliomas (Phase I)
The purpose of this research study is to learn whether anti-tumor T-cells and anti-tumor DC vaccines can be given safely. Most importantly, this study is also to determine whether the T-cells and DC vaccines can stimulate a person's immune system to fight off the tumor cells in the brain.
To determine the safety of adoptive cellular therapy in pediatric patients with HGG receiving dose intensified TMZ and DC+xALT therapy with and without HSCs.
1) Examine feasibility of completing treatment (administration of at least 3 DC vaccines) in enrolled subjects.
2) Comparison of baseline to post-immunotherapy functional anti-tumor immune responses.
3) Analysis of progression-free survival and overall survival after treatment with DC + xALT therapy with and without HSCs.
SCREENING ELIGIBILITY: Patients with histologically confirmed World Health Organization (WHO) Grade III or IV malignant glioma; Scheduled for definitive surgical resection of suspected high-grade gliomas (HGG) (biopsy only patients are not eligible for this study).
POST-SURGICAL RESECTION ELIGIBILITY FOLLOWS:
Histologically confirmed WHO Grade III or IV malignant glioma.
Residual post-surgical disease burden less than 3 cm as defined by longest perpendicular diameter of contrast enhancing tumor on post-operative MRI 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 peripheral blood stem cell (PBSC) harvest following registration.
Participants of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control while being treated on this study.
Participants with post-surgical neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration.
PRIOR TO FIRST VACCINE: Off corticosteroids or weaning to a minimal/stable dose of replacement steroids ≤ 4 mg/day within 1 week of scheduled DC vaccination.
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