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Clinical Trial 18752

Cancer Type: Neurologic Oncology
Study Type: Treatment
NCT#: NCT03334305

Phase: Phase I
Principal Investigator: Reed, Damon

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Study Title

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.



Chemotherapy (NOS); Immunotherapy; Radiotherapy; Surgery


Autologous Dendritic Cells (); Autologous Lymphocyte Infusion (); Hematopoietic Progenitor Cells (); Temodal (Temozolomide); Temozolomide ()

Inclusion Criteria

  • Age 3 years to 21 years
  • 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).
  • 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.

  • Exclusion Criteria

  • HGG biopsy only patients are not eligible for this study
  • Midline unresectable tumors
  • Gliomatosis Cerebri
  • Residual post-surgical disease burden > 3 cm as defined by longest perpendicular diameter of contrast enhancing tumor on MRI.
  • 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.
  • Significant renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), pulmonary, hepatic or other organ dysfunction.
  • Require corticosteroids above physiologic doses (>4mg/day or equivalent dexamethasone).
  • Severe or unstable concurrent medical conditions.
  • Prior allergic reaction to Temozolomide (TMZ), GM-CSF, or Td.
  • Unwilling or unable to receive treatment and undergo follow-up evaluations at the enrolled Sunshine Project Consortium treatment site.

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