NCT00257322

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
9.3 years until next milestone

Results Posted

Study results publicly available

April 26, 2016

Completed
Last Updated

October 31, 2018

Status Verified

February 1, 2018

Enrollment Period

3.8 years

First QC Date

November 18, 2005

Results QC Date

June 26, 2009

Last Update Submit

February 6, 2018

Conditions

Colon CancerRectal Cancer

Keywords

Metastatic colon cancerMetastatic rectal cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Response Rates and Overall Survival.

    24 Months

Study Arms (1)

GM-CSF

EXPERIMENTAL

Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m\^2 SQ QD with a cap of 500mcg SQ QD

Drug: GM-CSF

Interventions

GM-CSFDRUG

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

GM-CSF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Known allergic or other adverse reaction to GM-CSF
  • Chemotherapy administration more frequently than bi-weekly
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Related Publications (1)

  • Martinez M, Ono N, Planutiene M, Planutis K, Nelson EL, Holcombe RF. Granulocyte-macrophage stimulating factor (GM-CSF) increases circulating dendritic cells but does not abrogate suppression of adaptive cellular immunity in patients with metastatic colorectal cancer receiving chemotherapy. Cancer Cell Int. 2012 Jan 23;12(1):2. doi: 10.1186/1475-2867-12-2.

    PMID: 22270330DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsRectal Neoplasms

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Chao Family Comprehensive Cancer Center
Organization
University of California, Irvine
UCstudy@uci.edu
(877) 827-8839

Study Officials

  • Randall Holcombe, MD

    Chao Family Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cancer Center

Study Record Dates

First Submitted

November 18, 2005

First Posted

November 22, 2005

Study Start

April 1, 2003

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

October 31, 2018

Results First Posted

April 26, 2016

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)