A Pilot Study Assessing Intra-Metastasis Administration of Autologous KLH-pulsed Dendritic Cells With Tumoral Radiation Therapy in Patients With Metastatic Pancreatic Carcinoma

Inclusion Criteria:

• Pathologic diagnosis of pancreatic carcinoma
• Radiologic evidence of hepatic metastasis with at least one lesion > 2.0 cm that is amenable to ultrasound or CT guided intra-tumoral DC injection
• Age > 18
• Life expectancy > 3 months
• Karnofsky Performance Status > 70%
• Patients must not have received any anti-neoplastic chemotherapy, immunotherapy or radiotherapy for the four weeks preceding entry onto the study (six weeks for nitrosoureas and mitomycin C).
• Adequate baseline hematopoietic function defined as WBC (white blood cell) > 3000/mm3, hemoglobin > 9g/dl, and platelet count > 100,000/mm3.
• Adequate baseline organ function defined as creatinine < 2.0, total bilirubin < 2.0 mg/dl
• Patients taking warfarin are not eligible. Adequate coagulation function defined as PT (prothrombin time) < 15, INR < 1.5 and PTT (partial thromboplastin time) < 35.
• Ability to give informed consent

Exclusion Criteria:

• Previous anti-tumor vaccine therapy
• Prior hepatic irradiation
• Known brain metastases
• History of prior autoimmune diseases (e.g. SLE (systemic lupus erythematosus), rheumatoid arthritis, myasthenia gravis)
• Regular corticosteroid use within the past one year or any corticosteroid use in the four weeks preceding study entry
• Evidence of HIV infection, AIDS, Hepatitis B or Hepatitis C infection
• Active bacterial, fungal or viral infection
• Pregnancy or lactation; women of childbearing potential and men must agree to use effective contraception during the course of this clinical trial
• Uncontrolled or unstable medical conditions including angina, arrhythmias, bleeding, or thromboembolic conditions,
• Any medical or psychiatric illness that might compromise the patients ability to tolerate treatment