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Clinical Trial 18752

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

Phase: Phase I
Prinicipal Investigator: Damon Reed

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

ACTION Trial- Adoptive Cellular Therapy following Dose-Intensified Temozolomide in Newly-diagnosed Pediatric High-grade Gliomas (Phase I)

Summary

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.

Objective

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.

Treatments

Therapies

Medications

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).
  • 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.

    • 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.

    • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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