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| Sponsor: | University of Pittsburgh |
|---|---|
| Information provided by (Responsible Party): | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00669136 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Drug: AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Trial Testing Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma |
| Estimated Enrollment: | 25 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost
|
Drug: AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost
AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations| Contact: David Geller, MD | (412) 692-2001 | gellerda@upmc.edu |
| Contact: Gail Tribble, RN, BSN, OCN | (412) 647-8205 | tribbleg@upmc.edu |
| United States, California | |
| University of California | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Richard Finn, MD 310-794-6500 | |
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: David Geller, MD 412-692-2001 | |
| University of Pittsburgh Cancer Institute | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Gail Tribble, RN, BSN, OCN 412-647-8205 | |
| Principal Investigator: | David Geller, MD | University of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00669136 History of Changes |
| Other Study ID Numbers: | 04-101, R01 CA104524 |
| Study First Received: | April 25, 2008 |
| Last Updated: | January 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost AFP Immunization |
|
Carcinoma Liver Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Adenocarcinoma |