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.

Condition	Treatment or Intervention	Phase
recurrent adult primary liver cancer advanced adult primary liver cancer localized resectable adult primary liver cancer adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer	Procedure: biological response modifier therapy  Procedure: non-specific immune-modulator therapy  Vaccine: non-tumor cell derivative vaccine  Procedure: vaccine therapy  Drug: AFP gene hepatocellular carcinoma vaccine  Drug: Montanide ISA-51	Phase I Phase II

Further Study Details: 

OBJECTIVES: I. Determine the maximum tolerated dose of human alpha fetoprotein (hAFP) peptide immunization comprised of hAFP(137-145), hAFP(158-166), hAFP(325-334), and hAFP(542-550) when emulsified in Montanide ISA-51 in HLA-A*0201 positive patients with hepatocellular carcinoma. II. Determine the safety and toxicity of this regimen in these patients. III. Determine the antigen-specific immune response, overall survival, disease free survival, and progression free survival in patients treated with this regimen.

PROTOCOL OUTLINE: This is a dose escalation study. Patients receive human alpha fetoprotein (hAFP) peptide immunization comprising hAFP(137-145), hAFP(158-166), hAFP(325-334), and hAFP(542-550) emulsified in Montanide ISA-51 intradermally into the proximal extremities or anterior trunk draining inguinal and axillary lymph nodes on days 0, 14, 28, and 42. Cohorts of 3-6 patients receive escalating doses of hAFP peptide immunization until the maximum tolerated dose is determined (MTD). The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed for survival.

PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven hepatocellular carcinoma; Any stage
• HLA-A*0201 positive
• Alpha fetoprotein (AFP) positive tumor by immunohistochemistry OR AFP levels greater than 30 ng/mL
• No organ allografts
• No uncontrolled CNS metastasis; Patients with prior CNS metastasis are eligible if they have received prior CNS irradiation to control local tumor growth

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: At least 4 weeks since prior chemotherapy; No concurrent chemotherapy
• Endocrine therapy: No concurrent corticosteroids
• Radiotherapy: At least 4 weeks since prior radiotherapy
• Surgery: Not specified
• Other: At least 2 weeks since prior acute therapy for acute viral, bacterial, or fungal infection; No concurrent immunosuppressive therapy (e.g., cyclosporine)

--Patient Characteristics--

• Age: Over 18
• Performance status: Karnofsky 70-100%
• Life expectancy: Not specified
• Hematopoietic: Hemoglobin greater than 9.0 g/dL (transfusion independent); Platelet count greater than 50,000/mm3; WBC greater than 3,000/mm3; Absolute neutrophil count greater than 1,000/mm3
• Hepatic: Not specified
• Renal: Not specified
• Cardiovascular: No history of New York Heart Association class III or IV cardiac insufficiency or coronary artery disease; No ischemic heart disease that would increase risk
• Pulmonary: No lung disease that would increase risk; No dyspnea at rest
• Immunologic: Positive skin test to common antigens (tetanus and candida); No congenital or acquired condition leading to an inability to generate an immune response
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No opportunistic infection; No acute viral, bacterial, or fungal infection that requires specific therapy; HIV negative; No concurrent condition that would preclude study treatment; No allergy to reagents used in this study

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

Study chairs or principal investigators

James S. Economou,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000067782; UCLA-9905003; NCI-H00-0053
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  May 2, 2000
ClinicalTrials.gov Identifier:  NCT00005629
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08