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NCT00257322 · ClinicalTrials.gov registry record · Phase 2

Cellular Immune Augmentation in Colon and Rectal Cancer

A Phase 2 study of Colon Cancer and Rectal Cancer, sponsored by University of California, Irvine.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target
1
Study location

NCT00257322: Completed Phase 2 study of Colon Cancer and Rectal Cancer, sponsored by University of California, Irvine.

NCT00257322 is a Phase 2 study of Colon Cancer and Rectal Cancer that has completed, run by University of California, Irvine. The registered enrollment target is 20 participants, below the 4,456-participant average among 97 other Colon Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00257322, a Phase 2 study of Colon Cancer and Rectal Cancer, has completed, sponsored by University of California, Irvine.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Immunological dendritic cell and cellular immune responses to GM-CSF administered in conjunction with chemotherapy for patients with advanced colorectal cancer.

Interventions

  • DRUG GM-CSF

Study Locations (1)

California

  • Chao Family Comprehensive Cancer Center - Orange

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2003-04
Est. Completion 2007-01
Phase Phase 2
University of California, Irvine

368 total trials

What the finished NCT00257322 record still lists

NCT00257322 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 4,456-participant average among 97 other Colon Cancer trials with a reported enrollment target (100% lower).

The record links to 2 conditions, with Colon Cancer appearing as the primary indexed condition, and to 1 intervention - of which GM-CSF is the first listed.

NCT00257322 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT00257322 about?

NCT00257322 is a clinical study titled "Cellular Immune Augmentation in Colon and Rectal Cancer". 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 propo...

What is the current status of trial NCT00257322?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2003-04. Estimated completion is 2007-01.

What conditions does trial NCT00257322 study?

This clinical trial studies the following conditions: Colon Cancer, Rectal Cancer.

What interventions are being tested in trial NCT00257322?

The interventions under investigation include: GM-CSF (DRUG).

Who is sponsoring clinical trial NCT00257322?

This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00257322 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Colon Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00257322's enrollment target sits among peer trials

20 87th of 97 higher than 8 of 97 other Colon Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Colon Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00257322, the US trial registry maintained by the National Library of Medicine. NCT00257322 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.