Basic Information

Gene symbol TP53 Synonyms BCC7, BMFS5, LFS1, P53, TRP53 Type of gene protein-coding
Gene perturbation-related omics dataset PerturbAtlas | PertOrg
Description tumor protein p53

GTO ID GTC0007
Trial ID NCT00017173
Disease Head and Neck Cancer
Altered gene P53
Therapeutic/Target gene Therapeutic gene
TherapyGene transfer
Treatment INGN-201|Advexin|AdV5.CMV-p53
Co-treatment cisplatin|conventional surgery|radiation therapy
PhasePhase2
Recruitment statusTerminated
TitlePhase II Trial Of Surgery With Perioperative RPR/INGN 201 (Ad5CMV-p53) Gene Therapy Followed By Chemoradiotherapy For Advanced, Resectable Squamous Cell Carcinoma Of The Oral Cavity, Oropharynx, Larynx, and Pharynx
Year2003
CountryUnited States
Company sponsorSWOG Cancer Research Network
Other ID(s)CDR0000068658|U10CA032102|S0011
Vector information
Vectoradenovirus
ConstructAd5-CMV-p53
Vector typereplication-impaired adenovirus serotype 5 (Ad5) vector
Transgene/Inserted genehuman wild-type p53 gene
Regulatory elementa cytomegalovirus (CMV) promoter
Viral genome modificationThe E1 region of the parental adenovirus DNA is deleted.

Clinical Result

Cohort 1
Administration route injection
Dosage 2.5E12 vp/10 ml, 3 times
Pts 13
Age Adult, Older_Adult
Outcome The estimate of 1-year progression-free survival is 92%.
Adverse reactions 1/13(Anemia); 1/13(Anorexia); 1/13(Cough); 1/13(Dehydration); 1/13(Dyspnea); 1/13(Fatigue/malaise/lethargy); 1/13(Febrile neutropenia); 1/13(Hypokalemia); 1/13(Hyponatremia); 3/13(Leukopenia); 3/13(Lymphopenia); 2/13(Nausea); 2/13(Neutropenia/granulocytopenia); 1/13(Osteonecrosis); 3/13(RT-GI mucositis, NOS); 1/13(RT-focal dermatitis, not recall); 2/13(RT-pharyngeal dysphagia); 1/13(Renal failure); 1/13(SGOT increase); 1/13(SGPT increase); 1/13(Stomatitis/pharyngitis); 3/13(Vomiting); 1/13(Weight loss)
References PMID: 19770418

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