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

Phase 2
18 Years
Open (Enrolling)
Metastatic Colon Cancer, Metastatic Rectal Cancer

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Define immunological dendritic cell & cellular immune responses

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Randall Holcombe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chao Family Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:

UCI 02-60



Start Date:

April 2003

Completion Date:

December 2008

Related Keywords:

  • Metastatic Colon Cancer
  • Metastatic Rectal Cancer
  • Metastatic colon cancer
  • Metastatic rectal cancer
  • Colonic Neoplasms
  • Rectal Neoplasms



Chao Family Comprehensive Cancer Center Orange, California  92868