Gene Therapy in Treating Patients With Cancer of The Liver

Liver Cancer Clinical Trial

Official title:

Phase I Study of Percutaneous Injections of Adeno-Virus p53 Construct (ADENO-p53) for Hepatocellular Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003147
• Other study ID #: NCI-2012-02259
• Secondary ID: PCI-96-035NCI-T9
• Status: Terminated
• Phase: Phase 1
• First received: April 6, 2000
• Last updated: February 4, 2013
• Start date: February 1998

Study information

• Verified date: May 2000
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Phase I trial to study the effectiveness of gene therapy with the p53 gene in treating patients who have cancer of the liver that cannot be surgically removed. Inserting the p53 gene into a person's tumor may improve the body's ability to fight liver cancer.

Description:

OBJECTIVES:

I. Determine the safety of adenovirus p53 construct (adeno-p53) in patients with hepatocellular carcinoma.

II. Investigate the potential effects of intralesional adeno-p53 given by monthly percutaneous injections in these patients.

OUTLINE: This is a dose escalation, multicenter study.

Patients receive adenovirus p53 construct by percutaneous injection to a maximum of two lesions on day 1. Treatment is repeated every 28 days for up to 6 courses. In the absence of dose-limiting toxicity (DLT) in the first cohort of 6 patients treated, subsequent cohorts of 6 patients each receive escalating doses of the drug on the same schedule. If DLT occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and that dose is declared the maximum tolerated dose. Study treatment may continue in the absence of disease progression and unacceptable adverse events.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed unresectable hepatocellular carcinoma (HCC) or highly suspicious for HCC based on CT scan and elevated alfafetoprotein

• Measurable disease by abdominal CT scan Accessible (peripheral) lesions

• No metastatic disease

PATIENT CHARACTERISTICS:

• Age: Over 18

• Performance status: ECOG 0-2

• Life expectancy: At least 12 weeks

• Platelet count at least 60,000/mm3

• Absolute neutrophil count greater than 1,500/mm3

• Prothrombin time of no greater than 16 seconds after administration of fresh frozen plasma

• Bilirubin no greater than 3.0 mg/dL

• Creatinine less than 1.5 mg/dL

• Child's class A or B cirrhosis eligible

• No uncontrolled infection Not pregnant or breast feeding

• No unstable or severe intercurrent medical condition

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior chemotherapy

• At least 4 weeks since prior radiation therapy

• No prior hepatic transplantation

• No more than 1 prior systemic regimen for hepatocellular carcinoma allowed

• No concurrent therapy with other investigational agents

• No prior gene therapy

• No prior intralesional therapy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

Biological:
• Ad5CMV-p53 gene

Locations

Country	Name	City	State
United States	Albert Einstein Comprehensive Cancer Center	Bronx	New York
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,