Phase 1b Study of AdV-tk + Valacyclovir Combined With Radiation Therapy for Malignant Gliomas

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

January 31, 2010

Study Completion Date

January 31, 2011

Conditions
Malignant GliomaGlioblastoma MultiformeAnaplastic Astrocytoma
Interventions
BIOLOGICAL

AdV-tk

Three different dosing levels of AdV-tk (3x10e10, 1x10e11, 3X10e11) were evaluated. A single injection of AdV-tk at the assigned dose level was administered, followed by 14 days of the oral prodrug valacyclovir. Patients then received standard of care radiation therapy and chemotherapy.

DRUG

Valacyclovir

The oral prodrug valacyclovir was given beginning 1-3 days following the AdV-tk. Valacyclovir tablets were taken three times a day for a total of 14 days.

Trial Locations (2)

43210

The Ohio State University Medical Center, Dept Neurosurgery, Columbus

77030

The Methodist Hosptial, Houston

Sponsors
All Listed Sponsors
lead

Candel Therapeutics, Inc.

INDUSTRY

NCT00751270 - Phase 1b Study of AdV-tk + Valacyclovir Combined With Radiation Therapy for Malignant Gliomas | Biotech Hunter | Biotech Hunter