Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer

• Radiation Therapy
• Other Novel Therapy

Yi Lin, M.D.
(Lin.Yi@mayo.edu)
5072845096

Sean S Park, M.D.
(Park.Sean@mayo.edu)
5072848227

Thomas D Atwell, M.D.
(Atwell.Thomas@mayo.edu)

• Evaluate the safety of autologous dendritic cells and a vaccine (Prevnar) in treating patients with liver cancer that cannot be removed by surgery after undergoing radiotherapy.
• Identify and characterize responses of the immune system in patients with liver cancer treated with radiotherapy followed by autologous dendritic cells and a vaccine (Prevnar).

• Age ≥18 years
• Histologic confirmation of intrahepatic cholangiocarcinoma
• Unresectable intrahepatic cholangiocarcinoma
• Measurable or evaluable disease
• All lesions should be treatable by radiotherapy while meeting normal tissue constraints.
• Tumor lesions should be accessible using an ultrasound-guided approach for dendritic cell injection into the tumor
• No evidence of tumor outside of the liver (excluding tumor clots) by computed tomography (CT) or magnetic resonance imaging (MRI) scan
• Patients who are not candidates for surgical treatment or for ablation with curative intent Adequate organ functions
• ECOG Performance Status (PS) 0 or 1

• Co-morbid systemic illnesses or other severe concurrent disease
• Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Other active malignancy ≤3years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.
• Active autoimmune disease such as autoimmune hepatitis, Crohn’s disease, rheumatoid arthritis, Sjögrens’ disease, systemic lupus erythematosus, or similar conditions.
• Child Pugh class B or C cirrhosis of the liver
• Barcelona Clinic Liver Cancer (BCLC) stage D disease
• Previously received immune modulating therapies
• Corticosteroids ≤2 weeks prior to registration, including oral, IV, subcutaneous, or inhaled routes of administration. NOTE: Patients on chronic corticosteroids may enroll if they receive less than 10 mg/day of prednisone (or equivalent)
• Prior liver radiation, including radioembolization

• Computed tomography (CT) or magnetic resonance imaging (MRI) scan
• Bloodwork to determine baseline organ functions, tumor markers, and immune cells
• Apheresis (isolation) of immature white blood from a patient’s own blood

• Inflammatory symptoms such as fever, chills, nausea, vomiting, diarrhea, rash, can occur
• Pain at injection site