Cellular Immune Augmentation in Colon and Rectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chao Family Comprehensive Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00257322
First received: November 18, 2005
Last updated: March 23, 2016
Last verified: March 2016
  Purpose
While new treatments for metastatic and recurrent colorectal cancer have become available over the past several years, this disease remains incurable with a limited life expectancy from the time of diagnosis. New strategies for treatment of disseminated colorectal cancer are needed. Under this proposal, patients with advanced colorectal cancer will receive Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) to stimulate endogenous dendritic cells and enhance anti-tumor immune mechanisms. This will be combined with standard chemotherapy and patients will be followed for response and overall survival. Detailed correlative laboratory analysis will also be performed to define the extent of dendritic cell and cellular immune system stimulation.

Condition Intervention Phase
Colon Cancer
Rectal Cancer
Drug: GM-CSF
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Cellular Immune Augmentation in Colon and Rectal Cancer Therapy

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Participants Exhibiting Immune Response [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Immunological dendritic cell and cellular immune responses to GM-CSF administered in conjunction with chemotherapy for patients with advanced colorectal cancer.


Secondary Outcome Measures:
  • Response Rates and Overall Survival. [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
    Effect of cellular immune stimulation on response rates and overall survival. This is a secondary endpoint and while data will be recorded, a larger study with improved power will be necessary to confirm any improvements noted.


Enrollment: 20
Study Start Date: April 2003
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GM-CSF
Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m^2 SQ QD with a cap of 500mcg SQ QD
Drug: GM-CSF
250ug/m^2 SQ QD with a cap of 500mcg SQ QD

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have: metastatic, disseminated or recurrent colon or rectal cancer
  • Patient to receive weekly or biweekly chemotherapy for at least 4 cycles (4 weeks) Examples include: 5FU or 5FU/leucovorin given once weekly Irinotecan (single agent) given once weekly 5FU/leucovorin/irinotecan given once weekly
  • Patient must be able to be taught to administer GM-CSF subcutaneously

Exclusion criteria:

  • Known allergic or other adverse reaction to GM-CSF
  • Chemotherapy administration more frequently than bi-weekly
  • Pregnant or lactating women
  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: NCT00257322

Locations
United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Randall Holcombe, MD Chao Family Comprehensive Cancer Center
  More Information

Responsible Party: Chao Family Comprehensive Cancer Center, Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00257322     History of Changes
Other Study ID Numbers: UCI 02-60  2003-2876 
Study First Received: November 18, 2005
Results First Received: June 26, 2009
Last Updated: March 23, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Metastatic colon cancer
Metastatic rectal cancer

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

ClinicalTrials.gov processed this record on August 25, 2016