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

NCT ID: NCT01174368

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2017-04-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cancer macrobeads

Cancer Macrobead placement in abdominal cavity

Group Type: EXPERIMENTAL

Cancer Macrobead placement in abdominal cavity

Intervention Type: BIOLOGICAL

8 macrobeads per kilogram

Interventions

Cancer Macrobead placement in abdominal cavity

8 macrobeads per kilogram

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Rogosin Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barry H Smith, MD

Role: PRINCIPAL_INVESTIGATOR

The Rogosin Institute

Locations

The Rogosin Institute

New York, New York, United States

Countries

United States

Other Identifiers

1003010955

Identifier Type: -

Identifier Source: org_study_id