DC Migration Study for Newly-Diagnosed GBM

PHASE2CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

October 12, 2015

Primary Completion Date

October 31, 2020

Study Completion Date

October 31, 2020

Conditions
GlioblastomaAstrocytoma, Grade IVGiant Cell GlioblastomaGlioblastoma Multiforme
Interventions
BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

DRUG

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.

DRUG

Saline

0.4mL of saline given in the opposite groin 1 day before the fourth vaccine in all groups

DRUG

Basiliximab

Group III will receive basiliximab infusions (20 mg I.V) 1 week before the first vaccine and 1 week before the second vaccine.

Trial Locations (1)

27710

Duke University Medical Center, Durham

All Listed Sponsors
lead

Mustafa Khasraw, MBChB, MD, FRCP, FRACP

OTHER

NCT02366728 - DC Migration Study for Newly-Diagnosed GBM | Biotech Hunter | Biotech Hunter