Phase I Study Combining Replication-Competent Adenovirus-Mediated Suicide Gene Therapy With Chemoradiotherapy for the Treatment of Non-Metastatic Pancreatic Adenocarcinoma
The objectives of this study are:
To determine the toxicity and maximum tolerated dose (MTD) of the Ad5-yCD/mutTKSR39rep-ADP
adenovirus in combination with 5-fluorocytosine (5-FC) and valganciclovir (vGCV) prodrug
therapy and standard chemoradiation. Fifteen to 30 subjects (5 cohorts of 3 - 6 subjects
each) with non-metastatic, unresectable pancreatic cancer will receive a single intratumoral
injection of the Ad5-yCD/mutTKSR39rep-ADP adenovirus at one of five dose levels (1 x 10e10
vp, 3 x 10e10 vp, 1 x 10e11 vp, 3 x 10e11 vp, 1 x 10e12 vp) under endoscopic ultrasound
(EUS)-guidance. Beginning three days later, subjects will receive 3 weeks (15 days) of 5-FC
and vGCV prodrug therapy concomitant with a 6 week (30 day) course of capecitabine
chemotherapy and 54 Gy conformal radiotherapy.
The primary endpoint is toxicity at 12 weeks. Secondary endpoints are: 1) tumor
(radiological) response, 2) time to disease progression, 3) survival, 4) persistence of
Ad5-yCD/mutTKSR39rep-ADP adenoviral DNA in blood, 5) infectious Ad5-yCD/mutTKSR39rep-ADP
adenovirus in blood, and 6) HSV-1 TK gene expression in the pancreas.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
12 weeks post adenovirus injection
Munther Ajlouni, M.D.
Henry Ford Health System
United States: Food and Drug Administration
|Henry Ford Health System||Detroit, Michigan 48202|