- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00669136
Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma
December 1, 2015 updated by: Lisa H. Butterfield, Ph.D.
A Phase I/II Trial Testing Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90095
- University of California
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Eligible patients must have locoregionally treated HCC and have a prior AFP serum determination over the limit of normality for each laboratory.
- This study will enroll adults over the age of 18.
- Have had HCC with a history of serum AFP determination above the upper limit of normality for each laboratory.
- Both male and female patients may be enrolled. Premenopausal females who have not undergone a surgical sterilization procedure must have a negative pregnancy test prior to treatment. Sexually active females of child-bearing potential are required to use two forms of contraception, including a barrier method, for trial eligibility. Sexually active males should use an appropriate "double barrier" method of birth control (such as female use of a diaphragm, intrauterine device (IUD), or contraceptive sponge, in addition to male use of a condom.
- Be HLA-A2.1 positive (HLA-A*0201) by DNA subtyping, or HLA-A2 positive by flow cytometry with antibodies MA2.1 and BB7.2.
- Stage II to IVa HCC after locoregional therapy (surgical resection, radio-frequency ablation, cryoablation, ethanol injection, chemoembolization and radioembolization).
- Karnofsky Performance Status greater than or equal to 70 percent.
- No evidence of opportunistic infection in the year before enrollment.
- Adequate baseline hematological function as assessed by the following laboratory values within 30 days prior to study entry (day -30 to 0):
Hemoglobin > 9.0 g/dL (patients cannot be transfusion dependent) Platelets > 50,000/mm3 Absolute Neutrophil Count (ANC) > 1,000/mm3
- Conserved liver function with a Child-Pugh Class A or B.
- Ability to give informed consent.
Exclusion Criteria:
Patients who meet any one of the following criteria will be excluded from study entry:
- Any congenital or acquired condition leading to inability to generate an immune response, including concomitant immune suppressive therapy. The ability to adequately respond to recall skin test antigens will be tested before trial entry but a negative response to skin allergens will not be reason for exclusion.
- Concomitant steroid therapy or chemotherapy, or any of these treatments < 30 days before the first vaccination.
- Females of child-bearing potential (premenopausal and not surgically sterilized) must have a negative serum HCG pregnancy test (within Day 14 to Day 0).
- Acute infection: any acute viral, bacterial, or fungal infection, which requires specific therapy excluding HBV or HCV. Acute therapy must have been completed within 14 days prior to study treatment.
- HIV-infected patients (their ability to generate a cellular immune response is altered due to the CD4-dependent immunosuppressive effects of the HIV infection).
- Patients with any underlying conditions which would contraindicate therapy with study treatment (or allergies to reagents used in this study).
- Patients with organ allografts (they require prolonged immunosuppressive therapy).
- Patients with high serum titers of neutralizing anti-adenoviral antibodies (positive at greater than 1:128 dilution by serum AdV blocking assay, expected to be approximately 30% of patients, they have a greatly reduced ability to respond to the AdV boost).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: 1
AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost
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AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose Limiting Toxicity (DLT) and Phase II Recommended Dose (P2RD)
Time Frame: 6 months
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6 months
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Immunological response rate in PBMC as indicated by the ELISPOT assay
Time Frame: 6 months
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease-Free Survival (DFS)
Time Frame: six months
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six months
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Immunological response rate as indicated by optional DTH
Time Frame: six months
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six months
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Immunological response rate in PBMC as indicated by the tetramer assay
Time Frame: six months
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six months
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Immunological response rate in lymph nodes as indicated by the ELISPOT assay
Time Frame: six months
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six months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: James Pingpank, MD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
April 25, 2008
First Submitted That Met QC Criteria
April 28, 2008
First Posted (Estimate)
April 29, 2008
Study Record Updates
Last Update Posted (Estimate)
December 3, 2015
Last Update Submitted That Met QC Criteria
December 1, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-101
- R01CA104524 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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