Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
The Rogosin Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: Cancer Macrobead placement in abdominal cavity Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cancer macrobeads
Cancer Macrobead placement in abdominal cavity
 Biological: Cancer Macrobead placement in abdominal cavity
8 macrobeads per kilogram


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 16 months ]
    Data was not collected.


Secondary Outcome Measures :
  1. Number of Metastases [ Time Frame: 16 months ]
  2. Progression-free Survival [ Time Frame: 16 months ]
    No data was collected.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, New York
The Rogosin Institute
New York, New York, United States, 10021
Sponsors and Collaborators
The Rogosin Institute
Investigators
Layout table for investigator information
Principal Investigator: Barry H Smith, MD The Rogosin Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT01174368    
Other Study ID Numbers: 1003010955
First Posted: August 3, 2010    Key Record Dates
Results First Posted: October 17, 2018
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Adenocarcinoma
Carcinoma, Renal Cell
Disease Progression
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes
Kidney Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases