Clinical trial NCT00022334: Vaccine Therapy in Treating Patients With Liver Cancer
Official title: A Phase I/II Trial Testing Immunization With Dendritic Cells Pulsed With Four AFP Peptides in Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2003-01-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: OBJECTIVES:

* Determine the maximum tolerated dose of alpha-fetoprotein peptide-pulsed autologous dendritic cells in HLA-A\*0201-positive patients with hepatocellular carcinoma.
* Determine the safety and toxicity of this regimen in these patients.
* Determine the immunological effects of this regimen in these patients.
* Determine the progression-free survival and clinical responses in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive alpha-fetoprotein peptide-pulsed autologous dendritic cells intradermally on day 1. Treatment repeats every 2 weeks for a total of 3 doses in the absence of unacceptable toxicity.

Cohorts of 3-12 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 12 patients experience dose-limiting toxicity.

Patients are followed at weeks 1, 4, and 12 and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.

Eligibility criteria: 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.

Primary outcomes:
measure: Dose limiting toxicity and maximum tolerable dose.
timeFrame: 1 year
Secondary outcomes:
measure: Generation of AFP specific immunity.
timeFrame: 3 years
measure: Progression-free survival.
timeFrame: 3 years
measure: clinical response in patients with measurable disease.
timeFrame: 3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: James S. Economou, MD
role: PRINCIPAL_INVESTIGATOR
References: