Gene Therapy in Treating Patients With Cancer of The Liver

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Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ad5CMV-p53 gene

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring localized unresectable adult primary liver cancer, adult primary hepatocellular carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Albert Einstein Comprehensive Cancer Center
University of Pittsburgh Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm 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 treatment may continue in the absence of disease progression and unacceptable adverse events.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003147

First Posted

April 6, 2000

Last Updated

February 4, 2013

Sponsor

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00003147

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2000

Overall Recruitment Status

Terminated

Why Stopped

Administratively complete.

Study Start Date

February 1998 (undefined)

Primary Completion Date

June 2003 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cancer

Keywords

localized unresectable adult primary liver cancer, adult primary hepatocellular carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm 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 treatment may continue in the absence of disease progression and unacceptable adverse events.

Intervention Type

Biological

Intervention Name(s)

Ad5CMV-p53 gene

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chandra P. Belani, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Study Chair

Facility Information:

Facility Name

Albert Einstein Comprehensive Cancer Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

University of Pittsburgh Cancer Institute

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Liver Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial