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| ID | Type | Description | Link |
|---|---|---|---|
| UCLA-9905003 | |||
| NCI-H00-0053 |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFP gene hepatocellular carcinoma vaccine | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Survival |
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Inclusion Criteria
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.
Adequate baseline hematological function as assessed by the following laboratory values within 30 days prior to study entry (day -30 to 0):
Positive skin test to common antigens (tetanus and/or candida).
Ability to give informed consent and signed informed consent.
Exclusion Criteria
Patients who meet any one of the following criteria will be excluded from study entry:
All allowed medications or treatments should be kept to a minimum and recorded.
- Concomitant Medications and Treatments Not Allowed: Corticosteroids, Cyclosporin A, cytotoxic chemotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| James S. Economou, MD | Jonsson Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1781 | United States |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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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. |
| 1 month |
| D008107 |
| Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |