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Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic or Colorectal Cancer (Macrobead)

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ClinicalTrials.gov Identifier: NCT01053013
Recruitment Status : Recruiting
First Posted : January 21, 2010
Last Update Posted : May 4, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Colorectal Cancer Biological: Cancer macrobead placement in abdominal cavity Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase 2 Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Cell-Containing Agarose-Agarose Macrobeads in the Treatment of Patients With Treatment-Resistant, Metastatic Pancreatic or Colorectal Adenocarcinoma
Study Start Date : February 2010
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Arms and Interventions

Arm Intervention/treatment
Experimental: Cancer macrobeads
Cancer macrobead placement in abdominal cavity
Biological: Cancer macrobead placement in abdominal cavity
8 macrobeads per kilogram
Other Name: cancer macrobeads

Outcome Measures

Primary Outcome Measures :
  1. Tumor volume and number of metastases [ Time Frame: 16 months ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 16 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053013

Contact: Barry H Smith, MD, PhD 212-746-1551 bas2005@nyp.org
Contact: Nathaniel Berman, MD 212-746-9766 nab2009@nyp.org

United States, New York
Weill Cornell Medical College/The Rogosin Institute Recruiting
New York, New York, United States, 10021
Contact: Angelica Nazarian    212-746-9233    macrobead@nyp.org   
Contact: Nathaniel Berman, MD    212-746-9766    nab2009@nyp.org   
Principal Investigator: Thomas J. Fahey, M.D.         
Sub-Investigator: Nathaniel Berman, M.D.         
Sub-Investigator: Allyson Ocean, M.D.         
Sub-Investigator: Barry H. Smith, M.D., Ph.D.         
Sponsors and Collaborators
The Rogosin Institute
Study Director: Barry H Smith, MD, PhD The Rogosin Institute
More Information

Additional Information:
Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT01053013     History of Changes
Other Study ID Numbers: 0911010739
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by The Rogosin Institute:
mouse cells

Additional relevant MeSH terms:
Colorectal Neoplasms
Pancreatic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases