64
Participants
Start Date
October 12, 2015
Primary Completion Date
October 31, 2020
Study Completion Date
October 31, 2020
Unpulsed DCs
Patients in Group I will receive 1 x 10\^6 autologous unpulsed DCs in saline administered to a single side of the groin intradermally 1 day before the fourth vaccine.
Td
Patients in Groups II and III will receive a single dose of Td toxoid (1 flocculation unit, Lf, in 0.4 mLs) administered to a single side of the groin given intradermally 1 day before the fourth vaccine.
Human CMV pp65-LAMP mRNA-pulsed autologous DCs
2x10\^7 human CMV pp65-LAMP mRNA-pulsed autologous DCs are given intradermally and bilaterally at the groin site (divided equally to both inguinal regions). Patients will receive up to a total of 10 DC vaccines.
111In-labeled DCs
111In-labeled DCs are 2 x 10\^7 pp65-LAMP mRNA loaded mature DCs will be labeled with 111In (50 μCi / 5 x 10\^7 DCs) and given i.d. as fourth vaccine for Groups I and II only.
Temozolomide
Temozolomide is a standard chemotherapy given to all enrolled patients at a targeted dose of 150-200mg/m2/d for 5 days every 5 (± 1) weeks for a total of 6 to 12 cycles at the discretion of the treating oncologist.
Saline
0.4mL of saline given in the opposite groin 1 day before the fourth vaccine in all groups
Basiliximab
Group III will receive basiliximab infusions (20 mg I.V) 1 week before the first vaccine and 1 week before the second vaccine.
Duke University Medical Center, Durham
Mustafa Khasraw, MBChB, MD, FRCP, FRACP
OTHER