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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
  Purpose

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.


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 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

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 Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (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

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: July 30, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 24, 2014