RGD Reference Report - A phase I/II study of a MUC1 peptide pulsed autologous dendritic cell vaccine as adjuvant therapy in patients with resected pancreatic and biliary tumors.

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A phase I/II study of a MUC1 peptide pulsed autologous dendritic cell vaccine as adjuvant therapy in patients with resected pancreatic and biliary tumors.
Authors:	Lepisto, AJ Moser, AJ Zeh, H Lee, K Bartlett, D McKolanis, JR Geller, BA Schmotzer, A Potter, DP Whiteside, T Finn, OJ Ramanathan, RK
Citation:	Lepisto AJ, etal., Cancer Ther. 2008;6(B):955-964.
RGD ID:	2317987
Pubmed:	PMID:19129927 (View Abstract at PubMed)
PMCID:	PMC2614325 (View Article at PubMed Central)
Pancreatic and biliary cancers are relatively resistant to chemotherapy and radiation and may therefore provide an opportunity for testing the potential of immunotherapy. MUC1 is an epithelial cell glycoprotein that is highly overexpressed and aberrantly glycosylated in many adenocarcinomas, including pancreatic tumors, providing a tumor specific antigen and target. We performed a Phase I/II clinical trial of a MUC1 peptide-loaded DC vaccine in 12 pancreatic and biliary cancer patients following resection of their primary tumors. The primary endpoints were vaccine toxicity and immunogenicity and the secondary endpoint was clinical outcome. The vaccine was well tolerated and no toxicity was observed. Three patients had pre-existing MUC1 antibody responses that remained stable post vaccination. MUC1-specific T cell responses were difficult to evaluate due to increases in activity of all CD8 and CD4 T cells following each vaccination. Prior to vaccination, patients entered onto this trial had a significantly higher percentage of FoxP3+CD4+ T cells compared to age matched healthy controls. The percentage of these cells also increased transiently following each injection, returning to baseline or below before the next injection. Vaccinated patients have been followed for over four years and four of the twelve patients are alive, all without evidence of recurrence. Study of the immune parameters in long-term survivors several years after vaccination may yield the sought after immune correlates of clinical responses that analysis of immune responses shortly after vaccination has not revealed.

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Object Symbol	Species	Term	Qualifier	Evidence	With	Notes	Source	Original Reference(s)
MUC1	Human	biliary tract benign neoplasm		IDA			RGD
Muc1	Rat	biliary tract benign neoplasm		ISO	MUC1 (Homo sapiens)		RGD
Muc1	Mouse	biliary tract benign neoplasm		ISO	MUC1 (Homo sapiens)		RGD
MUC1	Human	pancreatic cancer		IDA			RGD
Muc1	Rat	pancreatic cancer		ISO	MUC1 (Homo sapiens)		RGD
Muc1	Mouse	pancreatic cancer		ISO	MUC1 (Homo sapiens)		RGD

Objects Annotated

Genes (Rattus norvegicus)

Muc1 (mucin 1, cell surface associated)

Genes (Mus musculus)

Muc1 (mucin 1, transmembrane)

Genes (Homo sapiens)

MUC1 (mucin 1, cell surface associated)

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A phase I/II study of a MUC1 peptide pulsed autologous dendritic cell vaccine as adjuvant therapy in patients with resected pancreatic and biliary tumors.