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.

Verified April 2013 by The Rogosin Institute

Sponsor:

Information provided by (Responsible Party):

The Rogosin Institute

ClinicalTrials.gov Identifier:

NCT01174368

First received: August 1, 2010

Last updated: April 8, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 1, 2010

Last Updated Date

April 8, 2013

Start Date ^ICMJE

June 2010

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01174368 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Biological: Cancer Macrobead placement in abdominal cavity

8 macrobeads per kilogram

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01174368

Other Study ID Numbers ^ICMJE

1003010955

Has Data Monitoring Committee

Yes

Responsible Party

The Rogosin Institute

Study Sponsor ^ICMJE

The Rogosin Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Barry H Smith, MD

The Rogosin Institute

Information Provided By

The Rogosin Institute

Verification Date

April 2013

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

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