Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Received Date ICMJE | April 25, 2008 | ||||||||
Last Updated Date | September 5, 2012 | ||||||||
Start Date ICMJE | June 2009 | ||||||||
Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
|
||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00669136 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma | ||||||||
Official Title ICMJE | A Phase I/II Trial Testing Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma | ||||||||
Brief 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). |
||||||||
Detailed Description | |||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 1 Phase 2 |
||||||||
Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
Condition ICMJE | Liver Cancer | ||||||||
Intervention ICMJE | Drug: AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost
AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost |
||||||||
Study Arm (s) | 1
AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost
Intervention: Drug: AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost |
||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 25 | ||||||||
Estimated Completion Date | December 2013 | ||||||||
Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Eligible patients must have locoregionally treated HCC and have a prior AFP serum determination over the limit of normality for each laboratory.
Hemoglobin > 9.0 g/dL (patients cannot be transfusion dependent) Platelets > 50,000/mm3 Absolute Neutrophil Count (ANC) > 1,000/mm3
Exclusion Criteria: Patients who meet any one of the following criteria will be excluded from study entry:
|
||||||||
Gender | Both | ||||||||
Ages | 18 Years to 80 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
|
||||||||
Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00669136 | ||||||||
Other Study ID Numbers ICMJE | 04-101, R01 CA104524 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | University of Pittsburgh | ||||||||
Study Sponsor ICMJE | University of Pittsburgh | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
|
||||||||
Information Provided By | University of Pittsburgh | ||||||||
Verification Date | September 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |