PMID- 21150717
OWN - NLM
STAT- MEDLINE
DCOM- 20110621
LR  - 20221207
IS  - 1537-4513 (Electronic)
IS  - 1524-9557 (Linking)
VI  - 34
IP  - 1
DP  - 2011 Jan
TI  - Phase 1 trial of Wilms tumor 1 (WT1) peptide vaccine and gemcitabine combination 
      therapy in patients with advanced pancreatic or biliary tract cancer.
PG  - 92-9
LID - 10.1097/CJI.0b013e3181fb65b9 [doi]
AB  - An open-labeled, dose-escalation phase 1 trial of Wilms tumor 1 (WT1) vaccine and 
      gemcitabine (GEM) combination therapy for patients with advanced pancreatic 
      cancer or biliary tract cancer was performed. The primary end point was 
      evaluation of toxicity, safety, and optimal immunologic dose of vaccine. Human 
      leukocyte antigen (HLA)-A 0201, HLA-A 0206, and/or HLA-A 2402-positive patients 
      with inoperable advanced pancreatic or biliary tract cancer who had not 
      previously been treated with GEM were eligible for this study. Six doses of GEM 
      and 4 doses of WT1 peptide (1 or 3 mg) emulsified in Montanide adjuvant were 
      administered over 2 months. Twenty-five patients (13 male and 12 female) were 
      enrolled. Nine patients had inoperable advanced pancreatic cancer, 8 had 
      gallbladder cancer, 4 had intrahepatic, and 4 had extrahepatic bile duct cancer. 
      The adverse events were comparable to those with GEM alone. Delayed-type 
      hypersensitivity test was positive after vaccination in 2 patients, and 
      WT1-specific T cells in peptide-stimulated culture were detected by tetramer 
      assay in 59% (13 of 22) of patients. The disease control rate at 2 months was 89% 
      for pancreatic cancer and 50% for biliary tract cancer. With a median follow-up 
      time of 259 days, the median survival time for biliary tract cancer was 288 days, 
      and that for pancreatic cancer was 259 days. Although objective clinical efficacy 
      was not apparent, the safety of WT1 vaccine and GEM combination therapy was 
      confirmed in this study.
FAU - Kaida, Miho
AU  - Kaida M
AD  - Department of Medical Oncology, National Cancer Research Center Hospital, 
      Chuo-ku, Tokyo, Japan.
FAU - Morita-Hoshi, Yuriko
AU  - Morita-Hoshi Y
FAU - Soeda, Atsuko
AU  - Soeda A
FAU - Wakeda, Takako
AU  - Wakeda T
FAU - Yamaki, Yuni
AU  - Yamaki Y
FAU - Kojima, Yasushi
AU  - Kojima Y
FAU - Ueno, Hideki
AU  - Ueno H
FAU - Kondo, Shunsuke
AU  - Kondo S
FAU - Morizane, Chigusa
AU  - Morizane C
FAU - Ikeda, Masafumi
AU  - Ikeda M
FAU - Okusaka, Takuji
AU  - Okusaka T
FAU - Takaue, Yoichi
AU  - Takaue Y
FAU - Heike, Yuji
AU  - Heike Y
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Immunother
JT  - Journal of immunotherapy (Hagerstown, Md. : 1997)
JID - 9706083
RN  - 0 (Antimetabolites, Antineoplastic)
RN  - 0 (Cancer Vaccines)
RN  - 0 (Cell Cycle Proteins)
RN  - 0 (Nuclear Proteins)
RN  - 0 (RNA Splicing Factors)
RN  - 0 (Vaccines, Subunit)
RN  - 0 (WTAP protein, human)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antimetabolites, Antineoplastic/adverse effects/*therapeutic use
MH  - Biliary Tract Neoplasms/drug therapy/*therapy
MH  - Cancer Vaccines/adverse effects/*therapeutic use
MH  - Cell Cycle Proteins
MH  - Combined Modality Therapy
MH  - Deoxycytidine/adverse effects/*analogs & derivatives/therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nuclear Proteins/*immunology
MH  - Pancreatic Neoplasms/drug therapy/*therapy
MH  - RNA Splicing Factors
MH  - Vaccines, Subunit/adverse effects/*therapeutic use
MH  - Gemcitabine
EDAT- 2010/12/15 06:00
MHDA- 2011/06/22 06:00
CRDT- 2010/12/15 06:00
PHST- 2010/12/15 06:00 [entrez]
PHST- 2010/12/15 06:00 [pubmed]
PHST- 2011/06/22 06:00 [medline]
AID - 00002371-201101000-00009 [pii]
AID - 10.1097/CJI.0b013e3181fb65b9 [doi]
PST - ppublish
SO  - J Immunother. 2011 Jan;34(1):92-9. doi: 10.1097/CJI.0b013e3181fb65b9.