Clinical trial NCT00005629: Vaccine Therapy in Treating Patients With Liver Cancer
Official title: Phase I/II Trial Testing Alpha Fetoprotein (AFP) Peptide Immunization in 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: 2003-10-01
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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):

  * Hemoglobin \> 8.5 g/dl (patients cannot be transfusion dependent).
  * Platelets \> 30,000/mm3
  * WBC \> 2,000/mm3
  * Absolute Neutrophil Count (ANC) \> 1,000/mm3
* 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:

* Any congenital or acquired condition leading to inability to generate an immune response, including concomitant immune suppressive therapy. The ability to adequately respond to antigens will be tested before trial entry by requiring a positive response to skin allergens (tetanus and candida).
* Lactating females: All patients must practice adequate birth control and females of child-bearing potential must have a negative serum HCG pregnancy test (within day -7 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, due to concerns in the ability to stimulate an effective immune response.
* Acute medical problems such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk.
* Patients with any underlying conditions that would contraindicate therapy with study treatment (or allergies to reagents used in this study).
* Patients with organ allografts.
* Uncontrolled hepatic insufficiency and cirrhosis, Class C in the Child's classification, with bilirubin \> 3 mg/dl, albumin \< 3.0 g/dl, poorly controlled ascites, advanced encephalopathy and poor nutritional status.
* Uncontrolled CNS metastasis. Patients with previously known CNS metastasis will be eligible if they have received CNS irradiation to control local tumor growth.
* Concomitant Medication and Treatment:

All allowed medications or treatments should be kept to a minimum and recorded.

- Concomitant Medications and Treatments Not Allowed: Corticosteroids, Cyclosporin A, cytotoxic chemotherapy.

Primary outcomes:
measure: Safety
timeFrame: 1 month
Secondary outcomes:
measure: antigen-specific immune response
timeFrame: 1 month
measure: Survival
timeFrame: 1 month
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: STUDY_CHAIR
References: