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 June 2015 by The Rogosin Institute
Sponsor:
Information provided by (Responsible Party):
The Rogosin Institute
ClinicalTrials.gov Identifier:
NCT01174368
First received: August 1, 2010
Last updated: June 10, 2015
Last verified: June 2015
  Purpose

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 Intervention Phase
Prostate Cancer
Biological: Cancer Macrobead placement in abdominal cavity
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The Rogosin Institute:

Primary Outcome Measures:
  • Tumor volume [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
  • Number of metastases [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 38
Study Start Date: June 2010
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cancer macrobeads
Cancer Macrobead placement in abdominal cavity
Biological: Cancer Macrobead placement in abdominal cavity
8 macrobeads per kilogram

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174368

Contacts
Contact: Barry H Smith, MD 212 746 1551 bas2005@nyp.org
Contact: Nathaniel Berman, MD 212-746-9766 nab2009@nyp.org

Locations
United States, New York
The Rogosin Institute Recruiting
New York, New York, United States, 10021
Contact: Barry H Smith, MD    212-746-1551    bas2005@nyp.org   
Contact: Nathaniel Berman, MD    212-746-9766    nab2009@nyp.org   
Sub-Investigator: Dr Nathaniel Berman, MD         
Sub-Investigator: Dr Allyson Ocean, MD         
Sponsors and Collaborators
The Rogosin Institute
Investigators
Principal Investigator: Barry H Smith, MD The Rogosin Institute
  More Information

Additional Information:
No publications provided

Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT01174368     History of Changes
Other Study ID Numbers: 1003010955
Study First Received: August 1, 2010
Last Updated: June 10, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma, Renal Cell
Disease Progression
Prostatic Neoplasms
Carcinoma
Disease Attributes
Genital Diseases, Male
Genital Neoplasms, Male
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on July 30, 2015