Gene Therapy in Treating Patients With Cancer of The Liver

February 4, 2013 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein Comprehensive Cancer Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: Ad5CMV-p53 gene

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Chandra P. Belani, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1998

Primary Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

April 6, 2000

First Submitted That Met QC Criteria

August 23, 2004

First Posted (Estimate)

August 24, 2004

Study Record Updates

Last Update Posted (Estimate)

February 5, 2013

Last Update Submitted That Met QC Criteria

February 4, 2013

Last Verified

May 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02259
  • PCI-96-035
  • NCI-T96-0059
  • CDR0000065932 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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