Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Liver Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed Over 18 NCI UCLA-0001026 NCI-G01-1997, NCT00022334

Objectives

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

Entry Criteria

Disease Characteristics:

• Diagnosis of hepatocellular carcinoma



• Alpha-fetoprotein level greater than 30 ng/mL



• HLA-A*0201 positive

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 corticosteroids

Radiotherapy:

• Not specified

Surgery:

• No prior organ allografts

Other:

• At least 14 days since prior therapy for acute infection
• No concurrent cyclosporine
• No concurrent immunosuppressive therapy

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
• Absolute neutrophil count greater than 1,000/mm³

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No New York Heart Association class III or IV cardiac insufficiency
• No coronary artery disease

Pulmonary:

• Oxygen saturation at least 91% on room air
• No dyspnea at rest

Other:

• Not pregnant
• Negative pregnancy test
• Fertile patients must use 2 methods of effective contraception
• HIV negative
• No prior opportunistic infection
• No congenital or acquired condition causing inability to generate immune response
• Positive response to skin allergens
• No acute viral, bacterial, or fungal infection requiring specific therapy
• No underlying condition that would preclude study participation
• No allergies to reagents used in study

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

James Economou, MD, Protocol chair		Ph: 310-794-6913; 888-798-0719

Registry Information
Official Title		A Phase I/II Trial Testing Immunization with Dendritic Cells Pulsed with Four AFP Peptides in Patients with Hepatocellular Carcinoma
Trial Start Date		2001-01-12
Registered in ClinicalTrials.gov		NCT00022334
Date Submitted to PDQ		2001-06-13
Information Last Verified		2004-10-29
NCI Grant/Contract Number		P30-CA16042, R01-CA77623

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