Clinical trial · Interventional
Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer
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
NCT00003433CI-TRIAL-00010935completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carcinoembryonic antigen RNA-pulsed DC cancer vaccine | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.