The Preston Robert Tisch Brain Tumor Center at Duke

Clinical Trials for Adults | Recurrent GBM Stem Cell Tumor Amplified RNA immunotherapy Trial

To learn the safety and effectiveness of brain tumor stem cells (BTSC) mRNA-loaded dendritic cells (DCs) in adult patients with first recurrent Glioblastoma multiforme (GBMs).

Patient Eligibility:

  • Age > 18 years of age
  • First recurrence of GBM (WHO Grade IV) with prior histologic diagnosis of GBM
  • No known contraindications to Avastin
  • KPS of ≥ 70%
  • RT with ≥ 45 Gy tumor dose, completed ≥ 8 weeks prior to study entry.

Study Plan:
Patients (within 4 weeks of resection) will undergo a procedure called “leukapheresis” where the patient’s white blood cells will be collected. Avastin, as part of standard of care therapy, will be initiated after the leukapheresis. Patients will then receive their first 3 dendritic cell (DC) vaccines at weekly intervals. DCs will be given intradermally and divided equally to both inguinal regions. An escalating total dose of mRNA-loaded DCs will be evaluated for purpose of establishing a maximally tolerated dose (MTD) and dose limiting toxicity (DLT). Beginning 1 week after vaccine 3, patients will undergo a second leakapheresis for immunologic monitoring with specific assessment of baseline antigen-specific cellular and humoral immune responses and for further DC generations. DC vaccinations at the same dose will then occur monthly until progression.  Immediately prior to each vaccination, blood will be obtained for immunologic monitoring. The need for additional leukaphereses for DC generation may be necessary, and if needed will be obtained at no more frequently than 3 month intervals.

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