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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174368
• Other study ID #: 1003010955
• Status: Completed
• Phase: Phase 2
• Start date: June 2010
• Est. completion date: April 2017

Study information

• Verified date: January 2019
• Source: The Rogosin Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Renal Cell
• Disease Progression
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• Cancer Macrobead placement in abdominal cavity
8 macrobeads per kilogram

Locations

Country	Name	City	State
United States	The Rogosin Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
The Rogosin Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Data was not collected.	16 months
Secondary	Number of Metastases		16 months
Secondary	Progression-free Survival	No data was collected.	16 months

External Links

•   Click here to learn more about the Macrobead Project