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Cellular Immune Augmentation in Colon and Rectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00257322
First Posted: November 22, 2005
Last Update Posted: April 26, 2016
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Chao Family Comprehensive Cancer Center, University of California, Irvine
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Cellular Immune Augmentation in Colon and Rectal Cancer Therapy

Further study details as provided by Chao Family Comprehensive Cancer Center, University of California, Irvine:

Primary Outcome Measures:
  • Participants Exhibiting Immune Response [ Time Frame: 24 Months ]
    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 ]
    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

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
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
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): 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 ( Other Identifier: University of California, Irvine )
First Submitted: November 18, 2005
First Posted: November 22, 2005
Results First Submitted: June 26, 2009
Results First Posted: April 26, 2016
Last Update Posted: April 26, 2016
Last Verified: March 2016

Keywords provided by Chao Family Comprehensive Cancer Center, 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