Expired Study
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Pittsburgh, Pennsylvania 15213


Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

NCI-2012-02259


NCT ID:

NCT00003147


Secondary ID:

PCI-96-035


Study Acronym:


Brief Title:

Gene Therapy in Treating Patients With Cancer of The Liver


Official Title:

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


Overall Status:

Terminated


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Administratively complete.


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Mask


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:February 1998
Primary Completion Date:June 2003
Primary Completion Type:Actual
Verification Date:May 2000
Last Changed Date:February 4, 2013
First Received Date:April 6, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:Ad5CMV-p53 gene
Arm Name:Arm I

Study Arms

Study Arm Type:Experimental
Arm Name:Arm I
Description: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 treatm

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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