NCT00669136

Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma

A Phase I/II Trial Testing Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Lisa H. Butterfield, Ph.D. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety, toxicity and immunological effects of adjuvant administration of an experimental therapy consisting on priming with three intramuscular administrations of a plasmid expressing human AFP (phAFP) together with a plasmid expressing human GM-CSF (phGM-CSF), followed by a single intramuscular boost with an AFP adenoviral vector (AdVhAFP) to patients with locoregionally pre-treated hepatocellular carcinoma (HCC).

Conditions

• Hepatocellular Carcinoma
• Hepatoma
• Liver Cancer, Adult
• Liver Cell Carcinoma
• Liver Cell Carcinoma, Adult
• Cancer of Liver
• Cancer of the Liver
• Cancer, Hepatocellular
• Hepatic Cancer
• Hepatic Neoplasms
• Hepatocellular Cancer
• Liver Cancer
• Neoplasms, Hepatic
• Neoplasms, Liver

Interventions

Type	Name	Description
DRUG	AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost	AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost

Timeline

• Start date: 2009-06-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2008-04-29
• Last updated: 2015-12-03

Locations

2 sites across 1 country: United States