Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003147
Status:
TERMINATED
Last Update Posted:
2013-02-05
First Post:
2000-04-06
Brief Title:
Gene Therapy in Treating Patients With Cancer of The Liver
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Percutaneous Injections of Adeno-Virus p53 Construct ADENO-p53 for Hepatocellular Carcinoma
Status:
TERMINATED
Status Verified Date:
2000-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons tumor may improve the bodys 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000065932 | REGISTRY | PDQ Physician Data Query | None |
| PCI-96-035 | None | None | None |
| NCI-T96-0059 | None | None | None |