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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by The Rogosin Institute
Information provided by (Responsible Party):
The Rogosin Institute Identifier:
First received: January 20, 2010
Last updated: May 23, 2016
Last verified: February 2016

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 Intervention Phase
Pancreatic Cancer
Colorectal Cancer
Biological: Cancer macrobead placement in abdominal cavity
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by The Rogosin Institute:

Primary Outcome Measures:
  • Tumor volume and number of metastases [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2010
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cancer macrobeads
Cancer macrobead placement in abdominal cavity
Biological: Cancer macrobead placement in abdominal cavity
8 macrobeads per kilogram
Other Name: cancer macrobeads


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01053013

Contact: Barry H Smith, MD, PhD 212-746-1551
Contact: Nathaniel Berman, MD 212-746-9766

United States, New York
The Rogosin Institute Recruiting
New York, New York, United States, 10021
Contact: Barry H Smith, MD, PhD    212-746-1551   
Contact: Nathaniel Berman, MD    212-746-9766   
Principal Investigator: Barry H Smith, MD, PhD         
Sub-Investigator: Nathaniel Berman, M.D.         
Sub-Investigator: Allyson Ocean, M.D.         
Sponsors and Collaborators
The Rogosin Institute
Principal Investigator: Barry H Smith, MD, PhD The Rogosin Institute
  More Information

Additional Information:
Responsible Party: The Rogosin Institute Identifier: NCT01053013     History of Changes
Other Study ID Numbers: 0911010739 
Study First Received: January 20, 2010
Last Updated: May 23, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by The Rogosin Institute:
mouse cells

Additional relevant MeSH terms:
Colorectal Neoplasms
Pancreatic Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Pancreatic Diseases
Rectal Diseases processed this record on May 24, 2016