Prostatic Neoplasms Clinical Trial
Official title:
Phase I-II Study HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer With or Without Metastatic Disease
The purpose of this study is to conduct a Phase I - II clinical trial to extend preclinical studies involving in situ HSV-tk + Valacyclovir gene therapy in combination with brachytherapy for recurrent prostate cancer. This will provide a novel therapeutic approach to prostate cancer and hopefully impact on the development of metastatic disease and the control of preexisting metastasis.
This investigational new drug application describes a proposed phase I/II study designed to
assess the safety and efficacy of AdV-tk gene therapy in combination with standard
brachytherapy for patients with locally recurrent prostate cancer after having failed
radiation as a primary treatment with or without minimal metastasis. These patients do not
have any standard treatment that has been demonstrated to have a high degree of efficacy in
eradicating the tumor with a reasonable degree of safety. Thus, the potential risks
associated with the use of gene therapy in this group would appear reasonable. This
application is for use of a replication defective adenovirus vector (ADV/RSV-tk) delivering
the HSV-tk gene as a biologic vector for gene therapy.
Direct introduction of therapeutic genes into malignant cells in vivo may provide an
effective treatment of solid tumors such as prostate cancer. The herpes simplex virus
thymidine kinase (HSV-tk) gene codes for an enzyme which phosphorylates the nucleoside
analog ganciclovir (GCV) into an intermediate that is incorporated into newly synthesized
DNA and terminates further replication, leading to cell death. Since normal mammalian cells
do not possess this enzyme, cytotoxicity depends on the successful introduction and
expression of the HSV-tk gene, phosphorylation of ganciclovir and synthesis of DNA.
Non-dividing cells may express HSV-tk and phosphorylate ganciclovir but are not harmed since
they do not synthesize DNA. This approach is especially suitable for the treatment of tumors
where rapidly dividing tumor cells are adjacent to tissues made up largely of
non-proliferating cells. Using human and animal models for prostate cancer we have
demonstrated that adenovirus-mediated transfer of the HSV-tk gene resulted in sensitivity to
ganciclovir in vitro and growth suppression of mouse prostate cancer in vivo.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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