Gene Therapy in Treating Patients With Cancer of The Liver

NCT ID: NCT00003147

Last Updated: 2013-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-02-28

Brief 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.

Detailed 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.

Conditions

Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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.

Group Type: EXPERIMENTAL

Ad5CMV-p53 gene

Intervention Type: BIOLOGICAL

Interventions

Ad5CMV-p53 gene

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chandra P. Belani, MD

Role: STUDY_CHAIR

University of Pittsburgh

Locations

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, United States

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PCI-96-035

Identifier Type: -

Identifier Source: secondary_id

NCI-T96-0059

Identifier Type: -

Identifier Source: secondary_id

CDR0000065932

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02259

Identifier Type: -

Identifier Source: org_study_id