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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by The Rogosin Institute
Sponsor:
Information provided by (Responsible Party):
The Rogosin Institute
ClinicalTrials.gov Identifier:
NCT01174368
First received: August 1, 2010
Last updated: May 23, 2016
Last verified: February 2016

August 1, 2010
May 23, 2016
June 2010
December 2016   (final data collection date for primary outcome measure)
  • Tumor volume [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
  • Number of metastases [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01174368 on ClinicalTrials.gov Archive Site
Progression-free survival [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Biological: Cancer Macrobead placement in abdominal cavity
8 macrobeads per kilogram
Experimental: Cancer macrobeads
Cancer Macrobead placement in abdominal cavity
Intervention: Biological: Cancer Macrobead placement in abdominal cavity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
38
December 2017
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Cancer of prostate
  • Evidence of metastasis
  • Failed available therapies
  • Resolution of any toxic effects of previous therapies
  • Performance status (ECOG PS) 0-2
  • Adequate hematologic, coagulation (INR 2-3max), hepatic and renal function
  • Life expectancy of 12 months
  • Agrees to contraceptive use while on study if sexually active
  • Sign informed consent document

Exclusion Criteria:

  • Any condition presenting an unacceptably high anesthetic or surgical risk
  • HIV positive
  • Cognitive impairment such as to preclude informed consent
  • Other surgical treatment, chemotherapy and radiation within four weeks of baseline
  • Inadequate hematologic, coagulation (INR >3), hepatic, renal function
  • Hepatic blood flow abnormalities and/or large-volume ascites
  • Concurrent cancer of any other type except skin cancer (excluding melanoma)
  • History of allergic reactions to mouse antigens
  • Active infection, congestive heart failure, unstable angina, serious cardiac arrhythmias, psychiatric illness, difficult social situations not permitting reliable participation, active bleeding
Male
18 Years and older   (Adult, Senior)
No
Contact: Barry H Smith, MD 212 746 1551 bas2005@nyp.org
Contact: Nathaniel Berman, MD 212-746-9766 nab2009@nyp.org
United States
 
NCT01174368
1003010955
Yes
Not Provided
Not Provided
The Rogosin Institute
The Rogosin Institute
Not Provided
Principal Investigator: Barry H Smith, MD The Rogosin Institute
The Rogosin Institute
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP