Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic or Colorectal Cancer
Conditions
Pancreatic Cancer - Colorectal Cancer
Conditions: official terms
Colorectal Neoplasms - Pancreatic Neoplasms
Conditions: Keywords
macrobead, biological, mouse cells
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cancer macrobead placement in abdominal cavity
Type: Biological
Overall Status
Recruiting
Summary
This is a clinical research study of an investigational (FDA IND-BB 10091) treatment for patients with pancreatic cancer (all stages) and advanced colorectal cancer that no longer responds to standard therapies.

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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Cancer of pancreas, colon or rectum

- Evidence of metastasis

- Failed available therapies (pancreatic cancer may be treated without previous therapies)

- Resolution of any toxic effects of previous therapies

- Performance status (ECOG PS) 0-2

- Adequate hematologic, coagulation (INR 2-3 max), hepatic and renal function

- Life expectancy of at least 6 weeks

- For females, a negative pregnancy test

- Agrees to contraceptive use while on study if sexually active

- Informed consent

Exclusion Criteria:

- Any condition presenting an unacceptably high anesthetic or surgical risk

- HIV positive

- Cognitive impairment such as to preclude informed consent

- Surgical treatment or chemotherapy within three weeks of scheduled macrobead implantation or within four weeks of bevacizumab (or similar drugs), or radiation therapy within four weeks of scheduled macrobead implantation

- 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
Location
The Rogosin Institute
New York, New York, United States
Status: Recruiting
Contact: Barry H Smith, MD, PhD - 212-746-1551 - bas2005@nyp.org
Start Date
February 2010
Sponsors
The Rogosin Institute
Source
The Rogosin Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page