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

The Rogosin Institute

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Biological: Cancer Macrobead placement in abdominal cavity

Study type

Interventional

Funder types

Other

Identifiers

NCT01174368

1003010955

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

Male

Ages

18+ years old

Volunteers

No 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