Gene Therapy in Treating Patients With Cancer of The Liver

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003147
First received: April 6, 2000
Last updated: February 4, 2013
Last verified: May 2000

April 6, 2000
February 4, 2013
February 1998
June 2003   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003147 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Gene Therapy in Treating Patients With Cancer of The Liver
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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Cancer
Biological: Ad5CMV-p53 gene
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.
Intervention: Biological: Ad5CMV-p53 gene
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
Not Provided
June 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003147
NCI-2012-02259, PCI-96-035, NCI-T96-0059, CDR0000065932
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Study Chair: Chandra P. Belani, MD University of Pittsburgh
National Cancer Institute (NCI)
May 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP