Study: NCT03334305

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: TTRNA-DC vaccines with GM-CSF
Description: After chemoradiation subjects will receive the first cycle of dose-intensified TMZ followed by three biweekly TTRNA-DC vaccines with GM-CSF. Monthly DC vaccines will be given during TMZ Cycles 2-5 for Groups A and B and 48-96 hours after completion of TMZ Cycle 6 Day 21 for Group A and 12-36 hours after HSCs for Group B. All subjects will receive an additional two bi-weekly vaccines during Cycle 6 for a total of 10 DC vaccines. All DC vaccines will be embedded with GM-CSF (150 µg per injection) and given intradermal.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: TTRNA-DC vaccines with GM-CSF
Description: After chemoradiation subjects will receive the first cycle of dose-intensified TMZ followed by three biweekly TTRNA-DC vaccines with GM-CSF. Monthly DC vaccines will be given during TMZ Cycles 2-5 for Groups A and B and 48-96 hours after completion of TMZ Cycle 6 Day 21 for Group A and 12-36 hours after HSCs for Group B. All subjects will receive an additional two bi-weekly vaccines during Cycle 6 for a total of 10 DC vaccines. All DC vaccines will be embedded with GM-CSF (150 µg per injection) and given intradermal.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dose-intensified TMZ
Description: After chemoradiation, subjects will receive the first cycle of dose-intensified TMZ followed by three biweekly TTRNA-DC vaccines with GM-CSF. All subjects will have an additional five cycles of dose-intensified TMZ (for a total of 6 Cycles) with concurrent monthly DC vaccinations.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dose-intensified TMZ
Description: After chemoradiation, subjects will receive the first cycle of dose-intensified TMZ followed by three biweekly TTRNA-DC vaccines with GM-CSF. All subjects will have an additional five cycles of dose-intensified TMZ (for a total of 6 Cycles) with concurrent monthly DC vaccinations.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Autologous Hematopoietic Stem cells (HSCs)
Description: Prior to chemoradiation, enrolled subjects will undergo a mobilized leukapheresis for collection of PBSCs and PBMCs for generation of DCs. One group will receive recommended dose of \> 2 x 106 CD34+ HSCs/kg. Subjects enrolled in Group B will receive HSCs during TMZ Cycle 6 before receiving DC vaccine and T-cell infusion.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: TTRNA-xALT
Description: During TMZ Cycle 6 and with DC vaccine #8, an infusion of T-cells will be administered to all subjects.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: TTRNA-xALT
Description: During TMZ Cycle 6 and with DC vaccine #8, an infusion of T-cells will be administered to all subjects.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Td vaccine
Description: A full Td booster vaccine will be administered IM at Vaccine #1 to all subjects, and vaccine site pretreatment will be administered to all subjects prior to Vaccine#3, #6, and #8.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Td vaccine
Description: A full Td booster vaccine will be administered IM at Vaccine #1 to all subjects, and vaccine site pretreatment will be administered to all subjects prior to Vaccine#3, #6, and #8.