Clinical trial · Interventional
Biological Therapy in Stage I, Stage II, or Stage III Surgically Resected Pancreatic Cancer
A Pilot Study of Active Immunotherapy With Carcinoembryonic Antigen Peptide-Pulsed, Autologous Human Cultured Dendritic Cells in Patients With Resected, Stage I, II and III Pancreatic Adenocarcinoma Expressing Carcinoembryonic Antigen
- 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)
Rational: White blood cells that have been treated with carcinoembryonic antigen peptide-1 may help the body build an immune response to and kill tumor cells that express CEA. Purpose: Phase II trial to study the effectiveness of white blood cells plus carcinoembryonic antigen peptide-1 in treating patients with stage I, stage II, or stage III pancreatic cancer that has been surgically removed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carcinoembryonic antigen peptide 1 | Biological | — | UNRESOLVED |
| hepatitis B antigen peptide | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Disease Characteristics: * Histologically confirmed stage I, II, or III adenocarcinoma of the pancreas Resected with no gross residual disease At least 50% of tumor cells must be CEA positive and stain with at least moderate intensity HLA-A2 positive Patient Characteristics: * Age: 18 and over * Performance status: Karnofsky 70-100% * Life expectancy: Greater than 6 months * Hematopoietic: Absolute neutrophil count at least 1000/mm3 * Hepatic: Bilirubin less than 2.0 mg/dL SGOT and alkaline phosphatase less than 4 times the upper limit of normal No hepatic failure * Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min * Cardiovascular: No New York Heart Association class III or IV heart disease * Pulmonary: No concurrent asthma or chronic obstructive pulmonary disease Other: * No other malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer within the past 5 years. * No history of autoimmune diseases such as inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, rheumatoid arthritis, or multiple sclerosis * No active acute or chronic infection such as urinary tract infection, HIV, or viral hepatitis * No active infectious enteritis or eosinophilic enteritis Not pregnant or nursing Fertile patients must use effective contraception Prior Therapy: * Biologic therapy: At least 4 weeks since immunotherapy. No other concurrent immunotherapy * Chemotherapy: At least 4 weeks since chemotherapy and recovered. No concurrent chemotherapy * Endocrine therapy: No concurrent corticosteroid or immunosuppressive therapy. At least 6 weeks since steroid therapy * Radiotherapy: At least 4 weeks since radiotherapy and recovered * Surgery: Recovered from prior surgery
References
Publications (0)
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