Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage II, Stage IIIA, Stage IIIB, or Stage IVA Liver Cancer
A Phase I/II Trial Testing Immunization With AFP + GM-CSF Plasmid Prime And AFP Adenoviral Vector Boost In Patients With Hepatocellular Carcinoma (AFP Prime-Boost Protocol)
- 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 DNA and a gene-modified virus may make the body build an immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of liver cancer. PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in treating patients with stage II, stage IIIA, stage IIIB, or stage IVA 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alpha fetoprotein adenoviral vector vaccine | Biological | — | UNRESOLVED |
| alpha fetoprotein plasmid DNA vaccine | Biological | — | UNRESOLVED |
| sargramostim plasmid DNA hepatocellular carcinoma vaccine adjuvant | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of hepatocellular carcinoma
* Stage II-IVA disease
* No active disease after local or regional therapy (e.g., surgical resection, radiofrequency ablation, cryoablation, or ethanol injection)
* Serum alpha fetoprotein \> upper limit of normal
* HLA-A\*0201 positive by DNA subtyping
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* Karnofsky 70-100%
Life expectancy
* Not specified
Hematopoietic
* Hemoglobin \> 9.0 g/dL (transfusion independent)
* Platelet count \> 50,000/mm\^3
* Absolute neutrophil count \> 1,000/mm\^3
Hepatic
* Child Pugh class A or B liver function
* Hepatitis B or C viral infection allowed
Renal
* Not specified
Cardiovascular
* No New York Heart Association class III or IV cardiac insufficiency
* No coronary artery disease
Immunologic
* HIV negative
* No other acute viral, bacterial, or fungal infection requiring therapy
* No allergy to study agents
* No history of opportunistic infection
* No high serum titer of neutralizing anti-adenoviral antibodies
* No congenital or acquired condition resulting in an inability to generate an immune response
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective double-method (including a barrier method) contraception
* No other condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 30 days since prior chemotherapy
* No concurrent cytotoxic chemotherapy
Endocrine therapy
* At least 30 days since prior steroid therapy
* No concurrent steroid therapy, including corticosteroids
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
* No prior organ allograft
Other
* At least 2 weeks since prior therapy for acute infection
* No concurrent immunosuppressive therapy
* No concurrent cyclosporineReferences
Publications (1)
- DERIVEDButterfield LH, Economou JS, Gamblin TC, Geller DA. Alpha fetoprotein DNA prime and adenovirus boost immunization of two hepatocellular cancer patients. J Transl Med. 2014 Apr 5;12:86. doi: 10.1186/1479-5876-12-86. PMID 24708667