Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer

NCT00003433 | Completed Phase 1

• 5 other identifiers: CDR0000066459DUMC-2031-00-11R3DUMC-2176-99-12R2DUMC-97146NCI-G98-1456
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

stage IV colon cancer; liver metastases

Interventions

carcinoembryonic antigen RNA-pulsed DC cancer vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Duke Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Herbert K. Lyerly, MD

  Duke Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 13, 2003
• Study Start: June 1, 1998
• Study Completion: August 1, 2003
• Last Updated: June 21, 2013

Record last verified: 2002-11

Locations

US (1)