Cellular Immune Augmentation in Colon and Rectal Cancer - Full Text View

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 II

MedlinePlus related topics:

Cancer Colorectal Cancer

ChemIDplus related topics:

Sargramostim Granulocyte-macrophage colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	A Pilot Study of Cellular Immune Augmentation in Colon and Rectal Cancer Therapy

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:

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

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

Keywords provided by University of California, Irvine:

Metastatic colon cancer

Metastatic rectal cancer

Study placed in the following topic categories:

Digestive System Neoplasms

Rectal Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Intestinal Neoplasms

Rectal neoplasm

Digestive System Diseases

Gastrointestinal Neoplasms

Colonic Neoplasms

Rectal cancer

Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00257322