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

NCT00669136 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2015-12-03

No results posted yet for this study

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

DRUG

AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost

AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Lisa H. Butterfield, Ph.D.

    lead OTHER

Principal Investigators

  • James Pingpank, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00669136 on ClinicalTrials.gov