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A Phase I/II Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed, Autologous, Cultured Dendritic Cells After Complete Resection of Hepatic Metastases of Colorectal Carcinoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Metastatic Cancer

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Trial Information

A Phase I/II Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed, Autologous, Cultured Dendritic Cells After Complete Resection of Hepatic Metastases of Colorectal Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Herbert K. Lyerly, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066459

NCT ID:

NCT00003433

Start Date:

June 1998

Completion Date:

August 2003

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • stage IV colon cancer
  • liver metastases
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710