Gene Therapy in Treating Patients With Cancer of The Liver

NCT00003147 | Terminated Phase 1

• 4 other identifiers: NCI-2012-02259PCI-96-035NCI-T96-0059CDR0000065932
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Liver Cancer

Keywords

localized unresectable adult primary liver cancer; adult primary hepatocellular carcinoma

Study Arms (1)

Arm I

EXPERIMENTAL

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

Interventions

Ad5CMV-p53 gene BIOLOGICAL

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

advexin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Chandra P. Belani, MD

  University of Pittsburgh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2000
• First Posted: August 24, 2004
• Study Start: February 1, 1998
• Primary Completion: June 1, 2003
• Last Updated: February 5, 2013

Record last verified: 2000-05

Locations

US (2)