Cellular Immune Augmentation in Colon and Rectal Cancer

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GM-CSF

Drug

250ug/m^2 SQ QD with a cap of 500mcg SQ QD

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2007
Study completion: 2007
First posted: Nov 22, 2005
Registry last updated: Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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