CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
GM-CSFdrug
Likely dose
GM-CSF 500mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00257322
NCT00257322Phase 2Completed
CompareCT.gov

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

University of California, Irvine·interventional·Posted Nov 22, 2005·Updated Oct 31, 2018

In Brief

A Phase 2 clinical trial evaluating GM-CSF for Colon Cancer and Rectal Cancer. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColon Cancer, Rectal Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 22, 2005
Enrollment StartApr 1, 2003
Primary CompletionJan 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.6 years ago

Interventions

GM-CSFdrug

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