Basic Information

Gene symbol TNF Synonyms DIF, TNF-alpha, TNFA, TNFSF2, TNLG1F Type of gene protein-coding
Gene perturbation-related omics dataset PerturbAtlas | PertOrg
Description tumor necrosis factor

GTO ID GTC0011
Trial ID NCT00051480
Disease Esophageal Cancer
Altered gene TNF
Therapeutic/Target gene Therapeutic gene
TherapyGene transfer
Treatment TNFerade
PhasePhase2
Recruitment statusCompleted
TitleA Single Arm, Phase II Study of TNFerade Biologic Gene Therapy + Radiation + 5-FU and Cisplatin in Locally Advanced, Resectable, Esophageal Cancer
Year2003
CountryUnited States
Company sponsorGenVec
Other ID(s)GV-001.005
Vector information
Vectoradenovirus
ConstructAd.Egr-TNF11D
Vector typereplication-deficient adenovirus serotype 5 vector
Transgene/Inserted genetumor necrosis factor-alpha gene
Regulatory elementradio- and chemo-inducible elements from the Egr-1 promoter upstream
Viral genome modificationThe E1, E3 and E4 region of the parental adenovirus DNA is deleted.

Clinical Result

Cohort1: dose level 1
Administration route intratumoral injection
Dosage 4E8 PU
Pts 7
Age Adult, Older_Adult
Outcome At the lower doses of 4E8 to 4E10 PU, thromboembolic events developed in 3 of 16 patients.
Adverse reactions fatigue; fever; nausea; esophagitis; vomiting; chills
References PMID: 22520270 | 19444302
Cohort2: dose level 2
Administration route intratumoral injection
Dosage 4E9 PU
Pts 4
Age Adult, Older_Adult
Outcome At the lower doses of 4E8 to 4E10 PU, thromboembolic events developed in 3 of 16 patients.
Adverse reactions fatigue; fever; nausea; esophagitis; vomiting; chills
References PMID: 22520270 | 19444302
Cohort3: dose level 3
Administration route intratumoral injection
Dosage 4E10 PU
Pts 5
Age Adult, Older_Adult
Outcome At the lower doses of 4E8 to 4E10 PU, thromboembolic events developed in 3 of 16 patients.
Adverse reactions fatigue; fever; nausea; esophagitis; vomiting; chills
References PMID: 22520270 | 19444302
Cohort4: dose level 4
Administration route intratumoral injection
Dosage 4E11 PU
Pts 8
Age Adult, Older_Adult
Outcome At the top dose of 4E11 PU, thromboembolic events developed in 5 of 8 patients. The median OS was 47.8 months. The 3-and 5-year OS rates and disease-free survival rates were 54% and 41% and 38% and 38%, respectively.
Adverse reactions fatigue; fever; nausea; esophagitis; vomiting; chills
References PMID: 22520270 | 19444302

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