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A Phase I/Pilot II Trial Combining Decitabine and Vaccine Therapy for Patients With Relapsed or Refractory Pediatric High Grade Gliomas, Medulloblastomas, and Central Nervous System Primitive Neuroectodermal Tumors (CNS PNETs)
The main purpose of this study is to determine the safety of using the combination of decitabine and a cancer vaccine plus Hiltonol. The vaccine will be made from the subject's blood cells and is designed to interact in the subject's body with cells that are programmed to fight specific tumor proteins NY-ESO-1, Melanoma Antigen Gene-A1 (MAGE-A1) and Melanoma Antigen Gene-A3 (MAGE-A3). The decitabine will be given to increase the amount and activity of these cancer proteins on the surface of tumor cells to increase the possibility that the vaccine will stimulate cells to act against the tumor cells. Subjects will be assessed to determine how these tumors respond to the treatment.
Details
| Lead sponsor | University of Louisville |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | TERMINATED |
| Enrolment | 1 |
| Start date | 2015-04 |
| Completion | 2016-07 |
Conditions
- Gliomas
- Medulloblastoma
- Neuroectodermal Tumors, Primitive
Interventions
- Vaccine (autologous dendritic cells)
- Decitabine and Hiltonol
Primary outcomes
- Tolerability (Number of Participants Without Adverse Events) — 20 weeks
Countries
United States