Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1998-06-30

Study Completion Date

2003-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Carcinoembryonic Antigen-loaded Dendritic Cells in Advanced Colorectal Cancer Patients

NCT00228189

Colorectal Cancer Liver Metastases

COMPLETED PHASE1/PHASE2

Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma

NCT01348256

Colorectal Carcinoma Hepatic Metastasis

UNKNOWN PHASE2

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

NCT00010127

Prostate Cancer

TERMINATED PHASE1

Immunotherapy for Colorectal Cancers Using CEA-Pulsed Dendritic Cells and Subsequent IL-2 Treatment

NCT00154713

Colorectal Cancer

UNKNOWN PHASE1/PHASE2

Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer

NCT00057915

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer Metastatic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

carcinoembryonic antigen RNA-pulsed DC cancer vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No