Combined Cytotoxic and Immune-Stimulatory Therapy for Glioma

PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

February 28, 2019

Study Completion Date

January 31, 2021

Conditions
Malignant GliomaGlioblastoma Multiforme
Interventions
BIOLOGICAL

Dose Escalation of Ad-hCMV-TK and Ad-hCMV-Flt3L

"Two adenoviral vectors will be used, each to deliver one of the therapeutic genes. Both vectors are human serotype 5, replication-defective, first generation adenoviral vectors deleted in E1a and E3 viral encoding regions. Each vector will constitutively express their respective therapeutic transgene (i.e. HSV1-TK or Flt3L) under the control of the human cytomegalovirus promoter (hCMV). Valacyclovir treatment will begin 1-3 days after vector administration at a dose of 2 grams given orally 3X per day for 14 days. A second course of valacyclovir will be given beginning Week 10.~Radiation and chemotherapy will be administered as per standard of care."

Trial Locations (1)

48109

University of Michigan Health System Department of Neurosurgery, Ann Arbor

All Listed Sponsors
collaborator

Phase One Foundation

OTHER

lead

University of Michigan Rogel Cancer Center

OTHER

NCT01811992 - Combined Cytotoxic and Immune-Stimulatory Therapy for Glioma | Biotech Hunter | Biotech Hunter