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

NCT01174368 | Completed Phase 2 Results DMC

• 1 other identifier: 1003010955
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Data was not collected.

  16 months

Secondary Outcomes (2)

• Number of Metastases

  16 months

• Progression-free Survival

  16 months

Study Arms (1)

Cancer macrobeads

EXPERIMENTAL

Cancer Macrobead placement in abdominal cavity

Biological: Cancer Macrobead placement in abdominal cavity

Interventions

Cancer Macrobead placement in abdominal cavity BIOLOGICAL

8 macrobeads per kilogram

Cancer macrobeads

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Rogosin Institute: lead

Study Sites (1)

The Rogosin Institute

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Angelica Nazarian
• Organization: The Rogosin Institute

212-746-1551

Study Officials

• Barry H Smith, MD

  The Rogosin Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2010
• First Posted: August 3, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: January 16, 2019
• Results First Posted: October 17, 2018

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)