Benign Pancreatic Neoplasm, Chronic Pancreatitis, Recurrent Acute Pancreatitis
Conditions
Brief summary
This phase I/II trial assesses the safety and effectiveness of total pancreatectomy with islet cell autotransplantation for the treatment of patients with long-term pancreatic inflammation (chronic pancreatitis) and non-cancerous (benign) pancreatic tumors. Total removal of the pancreas (pancreatectomy) can be used to treat chronic pancreatitis, but it may result in diabetes. An islet cell autotransplantation involves removing cells from a patient's pancreas (the islet cells) and infusing them into the liver. Islet cells are responsible for producing hormones like insulin, reducing the occurrence of diabetes in patients undergoing total pancreatectomy. Total pancreatectomy with autologous islet cell transplant is an accepted and Food and Drug Administration-approved treatment for patients with chronic pancreatitis. However, patients with chronic pancreatitis and pancreatic tumors have historically not been candidates for this procedure due to concerns of spreading potentially cancerous cells to other parts of the body. This clinical trial evaluates the safety and effectiveness of this treatment in patients with chronic pancreatitis and benign pancreatic tumors.
Detailed description
PRIMARY OBJECTIVE: I. To evaluate the oncologic safety of total pancreatectomy with islet cell autotransplantation (TPIAT) in chronic pancreatitis patients with benign pancreatic neoplasms. SECONDARY OBJECTIVES: I. To evaluate postoperative insulin requirements in patients with presumed benign pancreatic neoplasms undergoing TPIAT. II. To evaluate postoperative opiate requirements in patients with presumed benign pancreatic neoplasms undergoing TPIAT. III. To evaluate the postoperative survival of patients with presumed benign pancreatic neoplasms undergoing TPIAT. EXPLORATORY OBJECTIVES: I. To evaluate quality of life outcomes in patients undergoing TPIAT with presumed benign pancreatic neoplasms. II. To evaluate subjective pain-related outcomes in patients undergoing TPIAT with presumed benign pancreatic neoplasms. OUTLINE: Patients undergo total pancreatectomy and autologous islet cell transplant intravenously (IV) over 15-60 minutes on day 1. After completion of study treatment, patients are followed up for 2 years.
Interventions
PROCEDUREPancreatectomy
Undergo pancreatectomy
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERTreatment Planning
Undergo IV autologous islet cell transplant
Sponsors
Oregon Health and Science University
OHSU Knight Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed * Age\>= 18 years. Both men and women and members of all races and ethnic groups will be included. Gender-nonconforming and gender-fluid individuals as members of the general population will also be included * Participants must have adequate islet cell function (non-diabetic or C-peptide positive) * Participants must be indicated for total surgical resection of the pancreas for chronic pancreatitis-associated pain meeting eligibility criteria for TPIAT per University of Minnesota Criteria as defined by all of the following * Chronic abdominal pain of \> 6-month duration with at least one of the following: * Pancreatic calcification on computed tomography (CT) scan * At least two of the following: * Definite of suggestive diagnosis of chronic pancreatitis on endoscopic ultrasound * Ductal or parenchymal abnormalities compatible with chronic pancreatitis on secretin magnetic resonance cholangiopancreatography * Abnormal endoscopic pancreatic function tests (peak HCO2 \< 80mM) * Histopathology confirmed diagnosis of chronic pancreatitis * Compatible clinical history and documented hereditary pancreatitis gene mutation OR * History of recurrent acute pancreatitis (more than one episode of characteristic pain associated with imaging diagnostic of acute pancreatitis and/or elevated serum amylase or lipase \> 3 times upper limit of normal * At least one of the following: * Daily narcotic dependence * Pain resulting in impaired quality of life, which may include: inability to attend school, recurrent hospitalizations, or inability to participate in usual, age-appropriate activities. * Complete evaluation with no reversible cause of pancreatitis present or untreated * Failure to respond to maximal medical and endoscopic therapy * If clinical, radiologic, or biochemical evidence suggestive of cirrhosis or metabolic syndrome (defined in
Exclusion criteria
), the participant has undergone hepatology evaluation and been exonerated of a cirrhosis diagnosis or otherwise deemed to be at low hepatic risk from IAT * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 * Life expectancy of greater than 2 years * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with a prior or active non-pancreatic malignancy are eligible for this trial * Invasive abdominal surgical procedures such as pancreatectomy have the known potential to cause pregnancy loss. For this reason, persons of reproductive potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to undergoing pancreatectomy and IAT. Should a participant become pregnant or suspect a pregnancy prior to planned pancreatectomy and IAT, the participant should inform their treating physician immediately
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients that are free of metastatic disease to the liver from a pancreatic primary | From date of surgery to time of identification of metastatic disease from a pancreatic primary, assessed up to 2 years post-surgery or date of death due to metastatic disease of a pancreatic origin | The 95% confidence interval (CI) will be analyzed using the Clopper-Pearson exact interval method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin free rate | From date of surgery to 2 years post-surgery or death by any cause | Defined as proportion not requiring insulin for blood glucose control for at least 14 days prior to the assessment date at 2 years. The 95% CI will be analyzed using Clopper-Pearson exact interval method. |
| Opiates free rate | From date of surgery to 2 years post-surgery or death by any cause | Defined as proportion not receiving opiates for at least 14 days prior to the assessment date at 2 years.The 95% CI will be analyzed using Clopper-Pearson exact interval method. |
| Time to overall survival (OS) | From date of surgery to 2 years post-surgery or death by any cause | The time to OS distribution will be characterized using the Kaplan-Meier method. Kaplan-Meier curves of OS rate at 2 years will be estimated from the survival curve along with the 95% CI. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 2 years | AEs of grade 3 or greater will be collected and tabulated by the Medical Dictionary for Regulatory Activities version 21.1. By-patient listings will also be provided for the following: patient deaths, serious adverse events, and AEs leading to withdrawal. |
| Quality of life (QOL) | Up to 2 years | QOL scores will be collected over time using the Short Form 12. Summary of QOL and its change over time will be presented graphically using box plot and spaghetti plots, in addition to a summary table of QOL over time. |
| Pain-related outcomes | Up to 2 years | Subjective pain-related outcomes will be collected using Patient Reported Outcomes Measurement Information System Bank Pain Interference Survey, version 1.1 and will be analyzed similar to the QOL survey. |
Countries
United States
Contacts
Primary ContactBrett C Sheppard, MD
Outcome results
None listed