Histological or Cytological Diagnosis of Pancreatic Carcinoma Clinical Trial
Official title:
A Pilot Study to Evaluate Radiotherapy-Induced Ant-Tumor Immunity in Metastatic Carcinoma of the Pancreas
| NCT number | NCT01985958 |
| Other study ID # | UPCC 14213 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 2013 |
| Est. completion date | December 2019 |
| Verified date | April 2020 |
| Source | Abramson Cancer Center of the University of Pennsylvania |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Primary Objective: To estimate the rate at which radiotherapy to the primary or a metastatic
lesion produces an immune response in patients with metastatic carcinoma of the pancreas.
Secondary Objectives: To characterize the kinetics of an immune response induced by
radiotherapy. To characterize the dependency of the immune response on prior exposure to
chemotherapy.
| Status | Completed |
| Enrollment | 4 |
| Est. completion date | December 2019 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Histological or cytological diagnosis of pancreatic carcinoma - Patients = 18 years of age - Eastern Cooperative Oncology Group (ECOG) performance status 0,1,or 2 - Patients must have distant metastatic disease (stage 4) - Satisfactory organ and bone marrow function as defined by: Absolute neutrophil count> 1,000/uL, Platelets > 75,000uL Hemoglobin > 9 Bilirubin = 2.0x the institutional normal upper limit unless secondary to bile duct obstruction by tumor, - Creatinine = 1.5x the institutional normal upper limit - Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 5x the institutional normal upper limit. - A clinical recommendation for radiotherapy to the primary or a metastatic lesion had been made. - Must be able to provide informed consent. Exclusion Criteria: - No prior radiation to the area planned for radiotherapy - Active invasive cancer other than pancreatic adenocarcinoma. Non-melanoma skin cancer, superficial cervical or bladder cancer and prostate cancer with PSA level < 1.0 are not excluded. - Known HIV, HCV and/or HBV positive (by patient report/medical record) - Patients with ongoing or active infection - Planned concurrent treatment with systemic high dose corticosteroids. - Received an anticancer treatment (systemic therapy or radiation therapy)within 21 days prior to enrollment. - Immunotherapy (e.g. monoclonal antibodies)within 21 days prior to enrollment. - Immunosuppressive therapies (e.g. steroids, cyclosporine) are not permitted. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | One Year |