Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Macrobeads in the Treatment of Patients With Castration-Resistant Prostate Cancer Resistant to Docetaxel

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by The Rogosin Institute
Sponsor:
Information provided by (Responsible Party):
The Rogosin Institute
ClinicalTrials.gov Identifier:
NCT01174368
First received: August 1, 2010
Last updated: July 30, 2014
Last verified: July 2014

August 1, 2010
July 30, 2014
June 2010
December 2015   (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 the Treatment of Patients With Castration-Resistant Prostate Cancer Resistant to Docetaxel
An Open-Label, Phase 2 Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Cell-Containing Agarose- Agarose Macrobeads in the Treatment of Patients With Castration-Resistant Prostate Cancer Resistant to Docetaxel

This is a clinical research study of an investigational (FDA IND-BB 10091) treatment of subjects with castration-resistant prostate cancer resistant to docetaxel.

The treatment is being evaluated for its effect on tumor growth. It consists of small beads that contain mouse cancer cells from a mouse kidney cancer cell line. The cells in the beads produce substances that have shown to slow or stop the growth of tumors in experimental animals, veterinary patients, and 23 human subjects with different types of cancers in a Phase I safety trial.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
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 2016
December 2015   (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
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
The Rogosin Institute
The Rogosin Institute
Not Provided
Principal Investigator: Barry H Smith, MD The Rogosin Institute
The Rogosin Institute
July 2014

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