Prostate Cancer Clinical Trial
Official title:
An Open-Label, Phase II Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Cell-Containing Agarose-Agarose Macrobeads in the Treatment of Subjects With Castration-Resistant Prostate Cancer Resistant to Taxanes (Docetaxel, Cabazitaxel) and Evidence of Disease Progression on Androgen-axis Inhibition and/or Immunotherapy in the Form of Sipuleucel-T
This is a clinical research study of an investigational (FDA IND-BB 10091) treatment of
subjects with castration-resistant prostate cancer resistant to Taxanes (docetaxel,
cabazitaxel) and evidence of disease progression on androgen-axis inhibition and/or
immunotherapy in the form of sipuleucel-T.
The treatment is being evaluated for its effect on tumor growth. It consists of the placement
(implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA
macrobeads). The cells in the macrobeads produce substances that have been shown to slow or
stop the growth of tumors in experimental animals and veterinary patients. It has been tested
in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II
studies in patients with colorectal, pancreatic or prostate cancers are in progress.
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