Immunotherapy and SBRT Study in Borderline Resectable Pancreatic Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

June 30, 2016

Study Completion Date

July 30, 2016

Conditions
Pancreatic CancerPancreatic Carcinoma Non-resectable
Interventions
DRUG

mFOLFIRINOX

mFOLFIRINOX consisting of Oxaliplatin 85 mg/m\^2 IV over 2 hours; Irinotecan 180 mg/m\^2 IV over 90 minutes; Leucovorin 400 mg/m\^2 IV over 2 hours; Fluorouracil 2.4 g/m\^2 IV over 46 hours - given on days 15, 29, 43, 57, 71 and 85

BIOLOGICAL

Algenpantucel-L Immunotherapy

HAPa1 and HAPa2 immunotherapy components Algenpantucel-L Immunotherapy (HAPa) consisting of 300 Million HAPa cells given by intradermal injection for up to 28 doses total.

RADIATION

SBRT

Subjects that have at least stable disease at evaluation (day 93-100) are eligible to receive SBRT radiation given at 1.8 Gy per fraction for 28 fractions for a total dose of 50.4 Gy.

DRUG

Gemcitabine

"Gemcitabine 1000 mg/m\^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest.~Given as adjuvant treatment (days 1, 8 and 15) with 1 week rest for 6 cycles after surgical resection."

Trial Locations (4)

40292

University of Louisville, Louisville

87106

New Mexico Cancer Care Alliance, Albuquerque

98109

Seattle Cancer Care Alliance, Seattle

Unknown

Lahey Clinic, Burlington

Sponsors
All Listed Sponsors
lead

NewLink Genetics Corporation

INDUSTRY

NCT02405585 - Immunotherapy and SBRT Study in Borderline Resectable Pancreatic Cancer | Biotech Hunter | Biotech Hunter