Liver CancerPhase 1/2NCT00005629
Vaccine Therapy in Treating Patients With Liver Cancer
A Phase 1/2 study testing AFP gene hepatocellular carcinoma vaccine in people with Liver Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- AFP gene hepatocellular carcinoma vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1999to Jun 2002
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This study will enroll HLA-A 0201 adults over the age of 18 with history of biopsy-proven HCC and AFP positive by immunohistochemistry or serum AFP levels > 2 times above the upper limit of normality. Any stage of disease will be eligible.
- Both male and female patients may be enrolled. Females of childbearing potential must have a negative pregnancy test prior to treatment.
- Patients must be ambulatory with a Karnofsky Performance Status greater than or equal to 70 percent.
- No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease.
- No evidence of opportunistic infection.
- A minimum of 4 weeks must have elapsed since the completion of prior chemotherapy or radiation therapy.
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- Adequate baseline hematological function as assessed by the following laboratory values within 30 days prior to study entry (day -30 to 0):
- Hemoglobin > 8.5 g/dl (patients cannot be transfusion dependent).
- Platelets > 30,000/mm3
- WBC > 2,000/mm3
- Absolute Neutrophil Count (ANC) > 1,000/mm3
- Positive skin test to common antigens (tetanus and/or candida).
- Ability to give informed consent and signed 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 antigens will be tested before trial entry by requiring a positive response to skin allergens (tetanus and candida).
- Lactating females: All patients must practice adequate birth control and females of child-bearing potential must have a negative serum HCG pregnancy test (within day -7 to day 0).
- Acute infection: any acute viral, bacterial, or fungal infection, which requires specific therapy. Acute therapy must have been completed within 14 days prior to study treatment.
- HIV-infected patients, due to concerns in the ability to stimulate an effective immune response.
- Acute medical problems such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk.
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- Patients with any underlying conditions that would contraindicate therapy with study treatment (or allergies to reagents used in this study).
- Patients with organ allografts.
- Uncontrolled hepatic insufficiency and cirrhosis, Class C in the Child's classification, with bilirubin > 3 mg/dl, albumin < 3.0 g/dl, poorly controlled ascites, advanced encephalopathy and poor nutritional status.
- Uncontrolled CNS metastasis. Patients with previously known CNS metastasis will be eligible if they have received CNS irradiation to control local tumor growth.
- Concomitant Medication and Treatment:
- All allowed medications or treatments should be kept to a minimum and recorded.
- Concomitant Medications and Treatments Not Allowed: Corticosteroids, Cyclosporin A, cytotoxic chemotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
About this study
Official title: Phase I/II Trial Testing Alpha Fetoprotein (AFP) Peptide Immunization in Hepatocellular Carcinoma
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have liver cancer.
- Conditions
- Liver Cancer
- Being tested
- AFP gene hepatocellular carcinoma vaccine
- Keywords
- localized resectable adult primary liver cancer, localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFP gene hepatocellular carcinoma vaccineBiological
Patients will receive three biweekly intradermal vaccinations with four HLA-A*0201-binding AFP-derived peptides emulsified in 2 ml of Montanide ISA-51.
Group A AFP peptide dose 100 ug Group B AFP peptide dose 500 ug Group C AFP peptide dose 1000 ug
| Study group | Role | What they receive |
|---|---|---|
| Group A - first dosing group | Experimental | Patients will receive three biweekly intradermal vaccinations with four HLA-A*0201-binding AFP-derived peptides (100 ug dose) emulsified in 2 ml of Montanide ISA-51. Receives: Biological: AFP gene hepatocellular carcinoma vaccine |
| Arm B - dosing group 2 | Experimental | Patients will receive three biweekly intradermal vaccinations with four HLA-A*0201-binding AFP-derived peptides (500 ug dose) emulsified in 2 ml of Montanide ISA-51. Receives: Biological: AFP gene hepatocellular carcinoma vaccine |
| Group 3 - dosing level 3 | Experimental | Patients will receive three biweekly intradermal vaccinations with four HLA-A*0201-binding AFP-derived peptides (1000 ug dose) emulsified in 2 ml of Montanide ISA-51. Receives: Biological: AFP gene hepatocellular carcinoma vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Determine the safety of intradermal injection of the hAFP137-145 (PLFQVPEPV), hAFP158-166 (FMNKFIYEI), hAFP325-334 (GLSPNLNRFL) and hAFP542-550 (GVALQTMKQ) peptides emulsified in Montanide ISA-51.
Measured: 1 month
Secondary outcomes (2)
antigen-specific immune response
Determine the antigen-specific immune response to hAFP137-145 (PLFQVPEPV), hAFP158-166 (FMNKFIYEI), hAFP325-334 (GLSPNLNRFL) and hAFP542-550 (GVALQTMKQ), emulsified with Montanide ISA-51, in peripheral blood of patients with liver cancer.
Measured: 1 month
Survival
Determine the overall survival, disease-free survival or progression-free survival of patients with HCC vaccinated with hAFP137-145 (PLFQVPEPV), hAFP158-166 (FMNKFIYEI), hAFP325-334 (GLSPNLNRFL) and hAFP542-550 (GVALQTMKQ), emulsified with Montanide ISA-51.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2003 (estimated)
- Study startJul 1999
- Primary completionMay 2002
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- James S. Economou, MD, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005629
- Sponsor's protocol ID
- CDR0000067782
- Other IDs
- UCLA-9905003, NCI-H00-0053
- Status last verified
- Jul 2012
- First submitted
- 2 May 2000
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial Testing Alpha Fetoprotein (AFP) Peptide Immunization in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00005629
- Acronym / sponsor ID
- CDR0000067782
- Conditions
- Liver Cancer
- Keywords
- localized resectable adult primary liver cancer, localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 1999
- Primary completion
- May 2002 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 1 Oct 2003 (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.
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have liver cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - first dosing group | Experimental | Biological: AFP gene hepatocellular carcinoma vaccinePatients will receive three biweekly intradermal vaccinations with four HLA-A*0201-binding AFP-derived peptides (100 ug dose) emulsified in 2 ml of Montanide ISA-51. |
| Arm B - dosing group 2 | Experimental | Biological: AFP gene hepatocellular carcinoma vaccinePatients will receive three biweekly intradermal vaccinations with four HLA-A*0201-binding AFP-derived peptides (500 ug dose) emulsified in 2 ml of Montanide ISA-51. |
| Group 3 - dosing level 3 | Experimental | Biological: AFP gene hepatocellular carcinoma vaccinePatients will receive three biweekly intradermal vaccinations with four HLA-A*0201-binding AFP-derived peptides (1000 ug dose) emulsified in 2 ml of Montanide ISA-51. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- This study will enroll HLA-A 0201 adults over the age of 18 with history of biopsy-proven HCC and AFP positive by immunohistochemistry or serum AFP levels > 2 times above the upper limit of normality. Any stage of disease will be eligible.
- Both male and female patients may be enrolled. Females of childbearing potential must have a negative pregnancy test prior to treatment.
- Patients must be ambulatory with a Karnofsky Performance Status greater than or equal to 70 percent.
- No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease.
- No evidence of opportunistic infection.
Key exclusion criteria (13 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 antigens will be tested before trial entry by requiring a positive response to skin allergens (tetanus and candida).
- Lactating females: All patients must practice adequate birth control and females of child-bearing potential must have a negative serum HCG pregnancy test (within day -7 to day 0).
- Acute infection: any acute viral, bacterial, or fungal infection, which requires specific therapy. Acute therapy must have been completed within 14 days prior to study treatment.
- HIV-infected patients, due to concerns in the ability to stimulate an effective immune response.
- Acute medical problems such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk.
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 gene hepatocellular carcinoma vaccinePatients will receive three biweekly intradermal vaccinations with four HLA-A*0201-binding AFP-derived peptides emulsified in 2 ml of Montanide ISA-51. Group A AFP peptide dose 100 ug Group B AFP peptide dose 500 ug Group C AFP peptide dose 1000 ug | Biological | Arm B - dosing group 2, Group 3 - dosing level 3, Group A - first dosing group |
Primary outcome
Safety
Time frame: 1 month
Determine the safety of intradermal injection of the hAFP137-145 (PLFQVPEPV), hAFP158-166 (FMNKFIYEI), hAFP325-334 (GLSPNLNRFL) and hAFP542-550 (GVALQTMKQ) peptides emulsified in Montanide ISA-51.
2 secondary outcomes
antigen-specific immune response
Time frame: 1 month
Survival
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
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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 S. Economou, MD study chair
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AFP gene hepatocellular carcinoma vaccine in people with Liver Cancer, run by Jonsson Comprehensive Cancer Center at 1 site 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 13 inclusion and 13 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: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety (time frame: 1 month). 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 Aug 2020.