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 GTC0010
Trial ID NCT00044993
Disease Breast Cancer
Altered gene P53
Therapeutic/Target gene Therapeutic gene
TherapyGene transfer
Treatment INGN-201|Advexin|AdV5.CMV-p53
Co-treatment docetaxel|doxorubicin hydrochloride|conventional surgery|neoadjuvant therapy
PhasePhase2
Recruitment statusCompleted
TitlePhase II, Single Arm, Single Institution Clinical Trial of Docetaxel and Doxorubicin in Combination With Local Administration of INGN 201 (Ad5CMV-p53) in Locally Advanced Breast Cancer (LABC)
Year2002
CountryUnited States
Company sponsorIntrogen Therapeutics
Other ID(s)INTROGEN-201-010|CDR0000256223|MDA-ID-00008
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 intralesional injection
Dosage 2.5E12 vp
Pts 12
Age Adult, Older_Adult
Outcome 12/12(PR)
Adverse reactions 1/12(episode of febrile neutropenia); 1/12(episode of hypoglycemia); 1/12(hypotension); 3/12(skin inflammation; 2/12(fever); 1/12(fatigue); 1/12(myalgia); 1/12(breast pain); 1/12(anemia); 1/12(weight loss)
References PMID: 16874816

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