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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost
University of California
Los Angeles, California, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Dose Limiting Toxicity (DLT) and Phase II Recommended Dose (P2RD)
Time frame: 6 months
Immunological response rate in PBMC as indicated by the ELISPOT assay
Time frame: 6 months
Disease-Free Survival (DFS)
Time frame: six months
Immunological response rate as indicated by optional DTH
Time frame: six months
Immunological response rate in PBMC as indicated by the tetramer assay
Time frame: six months
Immunological response rate in lymph nodes as indicated by the ELISPOT assay
Time frame: six months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.