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Trial: NCT00003147 [RDF]

Label NCT00003147
Slug nct00003147
Trialid NCT00003147
Lookup name NCT00003147
Provenance http://clinicaltrials.gov/show/NCT00003147?displayxml=true
Lastchanged date February 4, 2013
Firstreceived results date
Firstreceived date April 6, 2000
Id info nct id NCT00003147
Overall status Terminated
Id info secondary id PCI-96-035
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 30
Number of arms 1
Is section 801 No
Is fda regulated Yes
Brief title Gene Therapy in Treating Patients With Cancer of The Liver
Acronym
Official title Phase I Study of Percutaneous Injections of Adeno-Virus p53 Construct (ADENO-p53) for Hepatocellular Carcinoma
Study type Interventional
Id info nct alias
Completion date
Verification date May 2000
Why stopped Administratively complete.
Id info org study id NCI-2012-02259
Required header url https://clinicaltrials.gov/show/NCT00003147
Study design Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Source National Cancer Institute (NCI)
Primary completion date June 2003
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on September 08, 2016
Phase Phase 1
Start date February 1998
Has expanded access No
Biospec descr
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.
Condition browse 8e913f2404fc005b67717b8d80c98ae5
Intervention browse None
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact None
Overall contact backup None
Sponsor group c165a369fd9845217790cd90ac3d544c
Oversight info United States: Food and Drug Administration (Oversight_info)
Eligibility 83296b24e46244d39c0f4e68940dc283
Keywords adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer
Conditions Liver Cancer
Locations 898775c18deef94ed8d883844a99b86e, d1d3cf04f35e32faa833b3df4216a0b5
Links None
Results references None
Arm groups Arm I (Arm Group)
Location countries United States
Interventions Ad5CMV-p53 gene (Intervention)
Secondary outcomes None
References None
Primary outcomes None
Removed countries None
Overall officials 12bfb86d68c1fd9a90dbbc47602f3fb1