| ClinicalTrials.gov Identifier |
| NCT03942328 |
| Institution Name |
| Mayo Clinic |
| Institution Address (Street) |
| 200 First Street SW |
| Institution City |
| Rochester |
| Institution State |
| Minnesota |
| Institution ZIP Code |
| 55905 |
| Institution Country |
| 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 |
