Clinical Trial: Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Macrobeads in 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
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Castr
Brief Summary:
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.
Detailed Summary:
Sponsor: The Rogosin Institute
Current Primary Outcome:
- Tumor volume [ Time Frame: 16 months ]
- Number of metastases [ Time Frame: 16 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Progression-free survival [ Time Frame: 16 months ]
Original Secondary Outcome: Same as current
Information By: The Rogosin Institute
Dates:
Date Received: August 1, 2010
Date Started: June 2010
Date Completion:
Last Updated: May 3, 2017
Last Verified: May 2017
