Liver Cancer Clinical Trial
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 (AFP Prime-Boost Protocol)
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.
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and maximum tolerated dose of adjuvant vaccination
comprising alpha fetoprotein (AFP) plasmid DNA and sargramostim (GM-CSF) plasmid DNA
followed by AFP adenoviral vector boost in patients with HLA-A*0201-expressing stage
II-IVA hepatocellular carcinoma.
Secondary
- Determine the optimal biological dose of this regimen, as defined by the generation of
AFP-specific immunity, in these patients.
- Determine disease-free survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of alpha fetoprotein (AFP) adenoviral vector boost.
Patients receive vaccination comprising AFP plasmid DNA and sargramostim (GM-CSF) plasmid
DNA intramuscularly (IM) on days 1, 30, and 60 in the absence of unacceptable toxicity.
Patients then receive boost immunization comprising AFP adenoviral vector IM and
intradermally on day 90.
Cohorts of 3-6 patients receive escalating doses of AFP adenoviral vector boost until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 3 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.
;
Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03213314 -
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
|
N/A | |
| Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT03756597 -
PAN-study: Pan-Cancer Early Detection Study (PAN)
|
||
| Recruiting |
NCT05160740 -
Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer
|
N/A | |
| Completed |
NCT01906021 -
Study of New Software Used During Ablations
|
N/A | |
| Terminated |
NCT04589884 -
Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
|
||
| Recruiting |
NCT05953337 -
Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)
|
N/A | |
| Enrolling by invitation |
NCT04466124 -
Prospective Cohort Study of Liver Cancer Patients Treated With Proton Beam Therapy
|
||
| Not yet recruiting |
NCT04053231 -
Hepatocarcinoma Recurrence on the Liver Study - Part2
|
||
| Active, not recruiting |
NCT02869217 -
Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors
|
Phase 1 | |
| Completed |
NCT03059238 -
Parecoxib Versus Celecoxib Versus Oxycodone in Pain Control for Transcatheter Chemoembolization Procedure
|
Phase 3 | |
| Recruiting |
NCT02632188 -
Radical Surgery Followed by Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen for the Treatment of Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT01388101 -
Real-time Diagnosis of Serum LECT 2 in Patient With Liver Cancer Using Electronic Antibody Sensor (e- Ab Sensor)
|
N/A | |
| Terminated |
NCT00903396 -
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
|
Phase 2 | |
| Completed |
NCT01042041 -
Sorafenib Tosylate and Chemoembolization in Treating Patients With Unresectable Liver Cancer
|
Phase 1 | |
| Completed |
NCT00980239 -
HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver
|
Phase 1 | |
| Completed |
NCT00790569 -
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
|
N/A | |
| Terminated |
NCT00896467 -
Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy
|
N/A | |
| Completed |
NCT00543777 -
Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease
|
Phase 1/Phase 2 |