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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01053013
Recruitment Status : Recruiting
First Posted : January 21, 2010
Last Update Posted : January 9, 2019
Information provided by (Responsible Party):
The Rogosin Institute

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 Biological: Cancer macrobead placement in abdominal cavity Phase 2

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 2019
Estimated Study Completion Date : December 2020

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

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01053013

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

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   
Contact: Nathaniel Berman, MD    212-746-9766   
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

Additional Information:
Responsible Party: The Rogosin Institute Identifier: NCT01053013     History of Changes
Other Study ID Numbers: 0911010739
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Rogosin Institute:
mouse cells

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases