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. 2013 Oct 22;2(12):e26662. doi: 10.4161/onci.26662

Table 1. Clinical trials of vaccine therapy in pancreas cancer.


Vaccine type

Investigator

Phase

Stage

Vaccine

Clinical and Immunology Outcomes

Peptide vaccines

KRAS-targeting vaccines

Gjertsen (1995)12

I/II

5 patients with histologically confirmed PDA

Mutated K-ras peptide

2 immune responders showed longer survival

Gjertsen (2001)13
I/II
48 patients, 10 surgically resected PDA, 38 with advanced PDA

Mutated K-ras peptide with GM-CSF

148 days in responders vs. 61 days in nonresponders

Abou-Alfa (2011)14

-

24 patients resected PDA

Mutated K-ras peptide

Median recurrence free survival 8.6 months;
Median overall survival 20.3 months
Telomerase-targeting vaccines
Bernhardt et al (2006)15

I/II

48 patients with unresectable PDA

Telomerase peptide (GV1001) with GM-CSF

Median overall survival 8.6 months in intermediate dose group

Gastrine based vaccine

Gilliam et al (2012)18

-

154 patients with advanced PDA, unwilling or unable to take chemotherapy

Gastrin peptide vaccine (G17DT) versus placebo

151 days G17DT vs. 82 days placebo p=0.03

HSP-peptide complex-based vaccines

Maki et al (2007)22

I

10 patients with resected PDA

HSPCC-96

Median overall survival was 2.2 years

Recombinant virus-based

MUC-1 and CEA in poxvirus

Kaufman et al (2007)23



I

10 patients with advanced stage PDA

TRICOM, MUC-1 and CEA in poxvirus with GM-CSF








15.1 months in responders vs. 3.9 months in nonresponders (p=0.002)

Listeria-based vaccines

Live attenuated Listeria vaccine

Le et al (2012)30

I
28 patients with mesothelioma, lung, pancreas, or ovarian cancer liver metastasis Live attenuated Listeria vaccine (ANZ-100) vs
Live attenuated mesothelin expressingListeria vaccine (CRS-207)
37% of patients in CRS-207 arm live after 15 months

Dentritic cell vaccines

MUC-1 pulsed autologous DC vaccine


Lepisto et al (2008)31

I/II

12 patients with resected pancreatic and biliary cancer

MUC-1 pulsed autologous DC vaccine

Median overall survival 26 months

DC-based vaccine plus LAK

Kimura et al (2012)32

-

49 patients with inoperable PDA (Stage III,, IVA, IVB)

DC-based vaccine plus LAK with gemcitabine or S-1

Median overall survival
of patients receiving DC vaccine and chemotherapy plus LAK cell therapy
was longer than those receiving DC vaccine in combination with
chemotherapy but no LAK cells
Whole cell vaccines

GM-CSF vaccine

Jaffee et al (2001)34

I

14 patients with resected PDA

GM-CSF vaccine with chemoradiotherapy

3 patients disease free at leas 25 months after diagnosis
 
Laheru et al (2008)35

II

50 patients with advanced PDA
GM-CSF vaccine (arm A)
Cy/GM-CSF vaccine(arm B)
Median overall survival in arm A : 2.3 months
Median overall survival in arm B: 4.3 months
 
Lutz et al (2012)36

II

60 patients with resected PDA

GM-CSF vaccine with chemotherapy (5FU) and radiotherapy

Median overall survival : 24.8 months
 
Le at al (2013)37

II

60 patients with metastatic PDA

2 doses of Cy/ GM-CSF vaccine followed by 4 doses CRS-207 (arm A)
6 doses ofCy/ GM-CSF vaccine (arm B)



Median overall survival was 6 months in Arm A vs. 3.4 months in Arm B (p=0.0114).

Algenpantucel-L

Hardacre et al (2010)38

II

62 patients with resected PDA

Algenpantucel-L with chemotherapy (gemcitabine and 5 FU)+ radiotherapy

12-month disease-free survival was 62 %, and the 12-month overall survival was 86 %.

Immune-modulating agents and vaccine combination therapys

Ipilimumab + Whole cell vaccines

Le et al (2012)48

Ib

30 patients with, local advanced, treatment refractory or metastatic PDA

Ipilimumab alone vsIpilimumab plus Cy/GM-CSF vaccine

Median overall survival in Ipilimumab alone : 3.3 months
Median overall survival in Ipilimumab alone : 5.5 months