Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Liver Cancer
A Phase I/II Trial Testing Immunization With Dendritic Cells Pulsed With Four AFP Peptides in Patients With Hepatocellular Carcinoma
NCT00022334CI-TRIAL-00046351completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins 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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AFP | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- See intervention description.
- interventionNames
- Biological: AFP
Primary outcomes (1)
- measure
- Dose limiting toxicity and maximum tolerable dose.
- timeFrame
- 1 year
Secondary outcomes (3)
- measure
- Generation of AFP specific immunity.
- timeFrame
- 3 years
- measure
- Progression-free survival.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * HLA-A\*0201 positive adults over the age of 18. * Have HCC with a serum AFP determination \>30ng/ml. * Both male and female patients may be enrolled. * 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 previous evidence of opportunistic infection. * Adequate baseline hematological function as assessed by the following laboratory values with 30 days prior to study entry: 1. Hemoglobin \>9.0g/dl 2. Platelets \>50000/mm3 3. Absolute Neutrophil Count \>1,000/mm3 * Child-Pugh Class A or B for chronic liver disease. * Ability to give informed consent. Exclusion Criteria: * Any congenital or acquired condition leading to inability to generate an immune response, including concomitant immune suppressive therapy. * Concomitant steroid therapy or chemotherapy, or any of these other treatments \< 30 days before the first vaccination. * Females of child-bearing potential must have negative serum beta-HCG pregnancy test (within Day -14 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. * Patients with any underlying conditions which would contraindicate therapy with study treatment. * Patients with organ allografts. * O2 sat \<91% on room air; dyspnea at rest.
References
Publications (0)
Data not yet available
No reference posted for this study.