Cellular Immune Augmentation in Colon and Rectal Cancer

University of California, Irvine20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colon Cancer Rectal Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 24 Months

Secondary Outcomes

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.