Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Metastatic Cancer |
Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 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 |
| Study Start Date: | June 1998 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Study Chair: | Herbert K. Lyerly, MD | Duke Cancer Institute |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003433 History of Changes |
| Other Study ID Numbers: | CDR0000066459, DUMC-2031-00-11R3, DUMC-2176-99-12R2, DUMC-97146, NCI-G98-1456 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 13, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV colon cancer liver metastases |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on June 13, 2013