Hepatocellular CarcinomaPhase 1NCT00669136
Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma
A Phase 1 study testing AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost in people with Hepatocellular Carcinoma and Hepatoma, run by Lisa H. Butterfield, Ph.D. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult
- What is being tested?
- AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Mar 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California
Los Angeles, California, 90095
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
About this study
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
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
- Being tested
- AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost
- Keywords
- AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost, AFP Immunization
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector BoostDrug
AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost Receives: Drug: AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT) and Phase II Recommended Dose (P2RD)
Measured: 6 months
Immunological response rate in PBMC as indicated by the ELISPOT assay
Measured: 6 months
Secondary outcomes (4)
Disease-Free Survival (DFS)
Measured: six months
Immunological response rate as indicated by optional DTH
Measured: six months
Immunological response rate in PBMC as indicated by the tetramer assay
Measured: six months
Immunological response rate in lymph nodes as indicated by the ELISPOT assay
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startJun 2009
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Poor accrual and limited target patient population for future accrual. Did not complete the Phase 1 portion of the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisa H. Butterfield, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Lisa H. Butterfield, Ph.D., University of Pittsburgh
- Investigators
- James Pingpank, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669136
- Sponsor's protocol ID
- 04-101
- Other IDs
- R01CA104524
- Status last verified
- Dec 2015
- First submitted
- 25 Apr 2008
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00669136
- Acronym / sponsor ID
- 04-101
- Conditions
- Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult, Cancer of Liver
- Keywords
- AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost, AFP Immunization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual and limited target patient population for future accrual. Did not complete the Phase 1 portion of the trial.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Lisa H. Butterfield, Ph.D.University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector BoostAFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector BoostAFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost | Drug | 1 |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Poor accrual and limited target patient population for future accrual. Did not complete the Phase 1 portion of the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Pingpank, MD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost in people with Hepatocellular Carcinoma and Hepatoma, run by Lisa H. Butterfield, Ph.D. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor accrual and limited target patient population for future accrual. Did not complete the Phase 1 portion of the trial.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) and Phase II Recommended Dose (P2RD) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.