Phase 2 Completed N=20 Treatment

Cellular Immune Augmentation in Colon and Rectal Cancer

Colorectal Cancer

Source: ClinicalTrials.gov NCT00257322 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2016

Primary outcomePrimary: Participants Exhibiting Immune Response — 11 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants Exhibiting Immune Response	11	—
SECONDARY Response Rates and Overall Survival.	16; 16	—

Eligibility 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
Pregnant or lactating women

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Data sourced from ClinicalTrials.gov (NCT00257322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.