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Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer

Primary Purpose

Colorectal Cancer, Metastatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
carcinoembryonic antigen RNA-pulsed DC cancer vaccine
Sponsored by
Duke Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, liver metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 20, 2013
Sponsor
Duke Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003433
Brief Title
Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
November 2002
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Duke Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Metastatic Cancer
Keywords
stage IV colon cancer, liver metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
carcinoembryonic antigen RNA-pulsed DC cancer vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert K. Lyerly, MD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer

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