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

ClinicalTrials.gov Identifier
NCT03942328
Institution Name
Mayo Clinic
Full Institution Address
200 First Street SW

Rochester
Minnesota
55905
United States
Institution Phone
(507) 284-2511
Institution Website
https://www.mayoclinic.org
Principal Investigator
Lewis R Roberts, M.B., Ch.B., Ph.D
Principal Investigator Phone
(507) 266-3239
Principal Investigator Email
Roberts.Lewis@mayo.edu
Additional Principal Investigators
Study Coordinator
Jaclynn Maria Wessling
Study Coordinator Phone
(507) 538-4545
Study Coordinator Email
Wessling.Jaclynn@mayo.edu
Study Overview
Early phase 1 study evaluating the safety of autologous dendritic cells (immune cells generated from patients' own white blood cells, grown in a special lab, and trained to stimulate the immune system against the tumor) and a vaccine (Prevnar) in treating patients with liver cancer that cannot be removed by surgery after undergoing radiotherapy.
Enrollment Information
26
Study Start Date
20190517
Study End Date
20261231
Study Purpose

  • 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).
Inclusion Criteria

  • 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
Exclusion Criteria

  • 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
Required Tests Prior to Study

  • 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
Potential Side Effects

  • Inflammatory symptoms such as fever, chills, nausea, vomiting, diarrhea, rash, can occur

  • Pain at injection site
Financial Assistance Available
No