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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01174368
Other study ID # 1003010955
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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