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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01174368|
Recruitment Status : Completed
First Posted : August 3, 2010
Results First Posted : October 17, 2018
Last Update Posted : October 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: Cancer Macrobead placement in abdominal cavity||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 2010|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||April 2017|
Experimental: Cancer macrobeads
Cancer Macrobead placement in abdominal cavity
Biological: Cancer Macrobead placement in abdominal cavity
8 macrobeads per kilogram
- Overall Survival [ Time Frame: 16 months ]Data was not collected.
- Number of Metastases [ Time Frame: 16 months ]
- Progression-free Survival [ Time Frame: 16 months ]No data was collected.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174368
|United States, New York|
|The Rogosin Institute|
|New York, New York, United States, 10021|
|Principal Investigator:||Barry H Smith, MD||The Rogosin Institute|