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Gene Therapy in Treating Patients With Cancer of The Liver

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ClinicalTrials.gov Identifier: NCT00003147
Recruitment Status : Terminated (Administratively complete.)
First Posted : August 24, 2004
Last Update Posted : February 5, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Liver Cancer Biological: Ad5CMV-p53 gene Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Percutaneous Injections of Adeno-Virus p53 Construct (ADENO-p53) for Hepatocellular Carcinoma
Study Start Date : February 1998
Actual Primary Completion Date : June 2003

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Arms and Interventions
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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


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003147


Locations
United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Study Chair: Chandra P. Belani, MD University of Pittsburgh
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003147     History of Changes
Other Study ID Numbers: NCI-2012-02259
PCI-96-035
NCI-T96-0059
CDR0000065932 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: August 24, 2004    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: May 2000

Keywords provided by National Cancer Institute (NCI):
localized unresectable adult primary liver cancer
adult primary hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases