Status:

COMPLETED

Cellular Immune Augmentation in Colon and Rectal Cancer

Lead Sponsor:

University of California, Irvine

Conditions:

Colon Cancer

Rectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 di...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2007

    Estimated Enrollment :

    20 Patients enrolled

    Trial Details

    Trial ID

    NCT00257322

    Start Date

    April 1 2003

    End Date

    January 1 2007

    Last Update

    October 31 2018

    Active Locations (1)

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    Chao Family Comprehensive Cancer Center

    Orange, California, United States, 92868