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CompletedNCT00003433Updated Jun 21, 2013

Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer

A Phase 1/2 interventional study of carcinoembryonic antigen RNA-pulsed DC cancer vaccine in Colorectal Cancer and Metastatic Cancer, sponsored by Duke Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-21.

Sponsored by Duke Cancer Institute · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Immunotherapy using CEA-treated white blood cells may help a person's body build an immune response to kill their tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of immunotherapy with CEA-treated white blood cells in treating patients with resected liver metastases from colon cancer.

Read the detailed description

OBJECTIVES:

  • Determine the cellular immune response to carcinoembryonic antigen pulsed dendritic cells in patients with adenocarcinoma of the colon metastatic to the liver.
  • Evaluate the overall and recurrence free survival in this patient population.

OUTLINE: Patients undergo leukapheresis for up to 4.5 hours to collect dendritic cells. The separated dendritic cells are pulsed with carcinoembryonic antigen (CEA) RNA. Patients receive CEA RNA pulsed dendritic cells intravenously every 2 weeks for a total of 4 doses. Patients undergo a second leukapheresis 2 weeks after the last dendritic cell infusion to obtain specimens for immunologic tests. Patients with extra doses of dendritic cells available may receive additional doses of CEA RNA pulsed dendritic cells every 2 months in the absence of unacceptable toxicity.

Patients are followed at weeks 12, 24, 36, and 48, and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study over 2 years.

02

Conditions studied

  • Colorectal Cancer
  • Metastatic Cancer

Keywords

  • stage IV colon cancer
  • liver metastases
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

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Lead sponsor

This is the only study on the registry with Duke Cancer Institute as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the colon metastatic to the liver that expresses carcinoembryonic antigen (CEA) after resection with curative intent

    • At least 50% of the tumor cells must stain positive for CEA with at least moderate intensity
  • No gross residual disease after surgery

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Greater than 6 months

Hematopoietic:

  • Absolute neutrophil count at least 1000/mm 3
  • Hemoglobin at least 9 g/dL
  • Platelet count at least 100,000/mm\^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • No chronic or acute hepatic disease

Renal:

  • Creatinine less than 2.5 mg/dL

Cardiovascular:

  • No chronic or acute cardiac disease (New York Heart Association class III or IV)

Pulmonary:

  • No chronic or acute pulmonary illness such as asthma or chronic obstructive pulmonary disease

Other:

  • Not pregnant or nursing
  • No other prior or concurrent malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer within the past 5 years
  • No history of autoimmune disease such as inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, and multiple sclerosis
  • No active acute or chronic infection such as urinary tract infection, HIV, or viral hepatitis
  • No active infectious enteritis or eosinophilic enteritis

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No other concurrent immunotherapy

Chemotherapy:

  • No concurrent chemotherapy
  • At least 6 weeks since prior chemotherapy

Endocrine therapy:

  • No concurrent steroid therapy (or any other immunosuppressives)
  • At least 6 weeks since prior steroid therapy

Radiotherapy:

  • No concurrent radiotherapy
  • At least 6 weeks since prior radiotherapy

Surgery:

  • Recovered from prior surgery
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
06

Study locations

1 site
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27710, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00003433
Lead sponsor
Duke Cancer Institute
First posted
Aug 13, 2003
Start date
Jun 1998
Completion
Aug 2003
Last update
Jun 21, 2013

Study contacts

Herbert K. Lyerly, MD
study chair · Duke Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2002. You cannot join it, but the record below documents what was studied.

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