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Cellular Immune Augmentation in Colon and Rectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by University of California, Irvine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00257322
First received: November 18, 2005
Last updated: March 21, 2008
Last verified: March 2008
History of Changes
  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 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
Metastatic Colon Cancer
Metastatic Rectal Cancer
 Drug: GM-CSF
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Define immunological dendritic cell & cellular immune responses [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Define the effect of cellular immune stimulation on response rates and overall survival. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2003
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GM-CSF
    250ug/m2 SQ QD with a cap of 500mcg SQ QD
  Eligibility

Ages Eligible for Study:   18 Years and older
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
  Contacts and Locations
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

No publications provided

Responsible Party: Randall Holcombe, MD, University of California, Irvine Medical Center
ClinicalTrials.gov Identifier: NCT00257322     History of Changes
Other Study ID Numbers: UCI 02-60
Study First Received: November 18, 2005
Last Updated: March 21, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 21, 2013