Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	Over 18	NCI, Other	CDR0000068806 UCLA-0001026, NCI-G01-1997, NCT00022334

Trial Description

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.

Further Study Information

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

DISEASE CHARACTERISTICS:

• Diagnosis of hepatocellular carcinoma

• Alpha-fetoprotein level greater than 30 ng/mL

• HLA-A*0201 positive

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/mm^3

• Absolute neutrophil count greater than 1,000/mm^3

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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Jonsson Comprehensive Cancer Center at UCLA

James S. Economou

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00022334
Information obtained from ClinicalTrials.gov on October 19, 2009

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