Study Name
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 (if applicable)
NCT03942328
Clinical Trial Category (check all that apply)
  • Radiation Therapy
  • Other Novel Therapy
Study Center
Institution Name
Mayo Clinic
Institution Address
200 First Street SW
City
Rochester
State
Minnesota
Zip Code
55905
Country
United States
Phone
(507) 284-2511
Website
https://www.mayoclinic.org
Study Contacts
Principal Investigator
Lewis R Roberts, M.B., Ch.B., Ph.D
P.I. Phone
(507) 266-3239
P.I. Email
Roberts.Lewis@mayo.edu
List additional Principal Investigators (include phone number and email)
Allan B Dietz, Ph.D.
(Dietz.Allan@mayo.edu)
5072664258

Christopher Leigh Hallemeier, M.D. (Hallemeier.Christopher@mayo.edu)
5072665232

Joleen Marie Hubbard, M.D. (Hubbard.Joleen@mayo.edu)
5072930487

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)

Study Coordinator
Jaclynn Maria Wessling
Study Coordinator Phone
(507) 538-4545
Study Coordinator Email
Wessling.Jaclynn@mayo.edu
OVERVIEW – in layman’s terms (150 words max)
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
26
Study Start Date
05/17/2019
Estimated Completion Date
05/01/2022
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • 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 – Patients Must:
  • 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 – Patients Must NOT:
  • 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 BEGINNING STUDY TREATMENT – in layman’s terms
  • 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 – in layman’s terms
  • Inflammatory symptoms such as fever, chills, nausea, vomiting, diarrhea, rash, can occur
  • Pain at injection site