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

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).

Timeline

Start

2009-06

Primary completion

2013-03

Completion

2013-03

Outcome

Outcome not reported

Stopped (Enrollment): “Poor accrual and limited target patient population for future accrual. Did not complete the Phase 1 portion of the trial.”

Drugs

Indications