Basic Information

Gene symbol tk

GTO ID GTC0569
Trial ID NTR129
Disease Prostate Cancer
Altered gene tk
Therapeutic/Target gene Therapeutic gene
TherapyGene transfer
Treatment Adv-HSV-tk
PhasePhase1
Recruitment statusCompleted
TitleNeoadjuvant pre-radical prostatectomy gene therapy (HSV-tk gene transduction followed by Ganciclovir) in patients with poor prognostic indicators.
Year2005
CountryDutch
Company sponsorErasmus Medical Center, Department of Urology
Other ID(s)ISRCTN21565532|NL98
Vector information
Vectoradenovirus
ConstructAdv.RSV-HSV-tk
Vector typeadenoviral vector
Transgene/Inserted geneherpes simplex virus (HSV) thymidine kinase gene
Regulatory elementthe Rous sarcoma virus (RSV) long terminal repeat promoter
Viral genome modificationThe E1 and E2 regions of the parental adenovirus DNA are deleted.
Vector production methodThe adenoviral vector was produced in the Baylor College of Medicine Gene Vector Laboratory, in accordance with Good Manufacturing Practice.

Clinical Result

Cohort 1
Administration route intra prostate injection
Dosage 2E10~2E11 vp
Pts 8
Age Adult, Older_Adult
Outcome Toxicity was minor in all 8 patients treated. In the prostate, no virus related cytopathic effect could be observed. Dose-dependent infiltration of T and B lymphocytes in the whole prostate and in tumor areas was observed. Boosting of adenovirus-specific antibody responses was observed in 7 patients, and an increased adenovirus-specific PBMC proliferation and IFN-gamma production was seen after Adv-HSV-tk stimulation.
Adverse reactions No serious clinical adverse events
References PMID: 15967266

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