Cellular Immune Augmentation in Colon and Rectal Cancer

Phase 2

Completed

• Conditions: Colon Cancer; Rectal Cancer
• Interventions: Drug: GM-CSF

• Registration Number: NCT00257322
• Lead Sponsor: University of California, Irvine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-11-18
• Study First Submitted QC: 2005-11-18
• Study First Posted: 2005-11-22
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Results First Submitted: 2009-06-26
• Results First Submitted QC: 2016-03-23
• Results First Posted: 2016-04-26
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GM-CSF	GM-CSF	Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m\^2 SQ QD with a cap of 500mcg SQ QD

Primary Outcome Measures

Name	Time	Method
Participants Exhibiting Immune Response	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

Name	Time	Method
Response Rates and Overall Survival.	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.

Trial Locations

Locations (1)

Chao Family Comprehensive Cancer Center; 🇺🇸 Orange, California, United States