11
Participants
Start Date
February 28, 2013
Primary Completion Date
February 28, 2018
Study Completion Date
February 28, 2018
Treatment
ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.
5FU
1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days
Mitomycin
10 mg/m2, day 1 and 29 (day 29 can be + 7 days)
IMRT
54 Gy in 30 fractions at 1.8 Gy per fraction.
Montefiore Medical Center, New York
Rhode Island Hospital, Providence
The Miriam Hospital, Providence
Lead Sponsor
Rhode Island Hospital
OTHER
The Miriam Hospital
OTHER
Brown University
OTHER