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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by The Rogosin Institute
Sponsor:
Information provided by (Responsible Party):
The Rogosin Institute
ClinicalTrials.gov Identifier:
NCT01053013
First received: January 20, 2010
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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 small beads that contain mouse cancer cells from a mouse kidney cancer cell line. The cells in the beads produce substances that have been shown to slow or stop the growth of tumors in experimental animals, veterinary patients, and 23 humans with different types of cancers in a Phase 1 safety trial.


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 Study Completion Date: October 2016
Estimated Primary Completion Date: August 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01053013

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

Locations
United States, New York
The Rogosin Institute Recruiting
New York, New York, United States, 10021
Contact: Barry H Smith, MD, PhD    212-746-1551    bas2005@nyp.org   
Contact: Nathaniel Berman, MD    212-746-9766    nab2009@nyp.org   
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
Investigators
Principal Investigator: Barry H Smith, MD, PhD The Rogosin Institute
  More Information

No publications provided

Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT01053013     History of Changes
Other Study ID Numbers: 0911010739
Study First Received: January 20, 2010
Last Updated: July 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The Rogosin Institute:
macrobead
biological
mouse cells

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

ClinicalTrials.gov processed this record on September 18, 2014