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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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cancer Macrobead placement in abdominal cavity
Sponsored by
The Rogosin Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Rogosin Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cancer macrobeads

Arm Description

Cancer Macrobead placement in abdominal cavity

Outcomes

Primary Outcome Measures

Overall Survival
Data was not collected.

Secondary Outcome Measures

Number of Metastases
Progression-free Survival
No data was collected.

Full Information

First Posted
August 1, 2010
Last Updated
January 7, 2019
Sponsor
The Rogosin Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01174368
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 2010 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Rogosin Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cancer macrobeads
Arm Type
Experimental
Arm Description
Cancer Macrobead placement in abdominal cavity
Intervention Type
Biological
Intervention Name(s)
Cancer Macrobead placement in abdominal cavity
Intervention Description
8 macrobeads per kilogram
Primary Outcome Measure Information:
Title
Overall Survival
Description
Data was not collected.
Time Frame
16 months
Secondary Outcome Measure Information:
Title
Number of Metastases
Time Frame
16 months
Title
Progression-free Survival
Description
No data was collected.
Time Frame
16 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry H Smith, MD
Organizational Affiliation
The Rogosin Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Rogosin Institute
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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