Cellular Immune Augmentation in Colon and Rectal Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Colon Cancer, Rectal Cancer

Intervention / Treatment
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* Drug: GM-CSF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GM-CSF<br>Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m^2 SQ QD with a cap of 500mcg SQ QD | Drug: GM-CSF<br>* 250ug/m^2 SQ QD with a cap of 500mcg SQ QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Exhibiting Immune Response | Immunological dendritic cell and cellular immune responses to GM-CSF administered in conjunction with chemotherapy for patients with advanced colorectal cancer. | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rates and Overall Survival. | 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. | 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic colon cancer, Metastatic rectal cancer