Endoscopic Abraxane Injection Into Pancreatic Cysts

Study Overview
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Brief Summary
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This research study is a pilot study. In this pilot study we are testing the safety of a procedure. Investigational means that the Albumin bound paclitaxel (Abraxane) is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved Abraxane injection for your type of medical condition. Treatment of pancreatic cysts often requires follow-up imaging studies and surgical resection of the cysts. As part of standard medical care, you will be undergoing a diagnostic endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in order to evaluate type of the cyst. During the EUS and just after the cyst fluid aspiration, you will undergo the injection of the drug into the cyst cavity if your cyst is thought to be cancerous or precancerous. Cyst fluid will be analyzed for further diagnosis.

Detailed Description
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You will be asked to undergo some screening tests or procedures to find out if you can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. Screening tests include the following: medical history, performance status, assessment of pancreatic cyst by CT, MRI or EUS, blood tests and a pregnancy test. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria you will not be able to participate in this research study. As part of your medical care you will be undergoing an endoscopic procedure EUS-FNA (Endoscopic Ultrasound Fine Needle Aspiration) in order to evaluate and evacuate the cyst fluid. During the EUS-FNA and just after the cyst fluid aspiration, albumin bound paclitaxel will be injected into the cyst cavity. The study procedure (injection of drug into cyst cavity) takes place over 5 minutes during the EUS-FNA. 2 days after the procedure you will receive a phone call from the research coordinator to check on how you are feeling. 3 months after study procedure participants will undergo a follow up CT to see what happened to the cyst. You will continue to have routine follow up for your medical problems.

Official Title
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EUS Guided Injection of Albumin Bound Paclitaxel Into Pancreatic Cysts

Conditions
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Pancreatic Cysts

Intervention / Treatment
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* Drug: Albumin bound paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mucinous cysts (premalignant or malignant cysts of the pancreas) Normal organ and marrow function Baseline CT within 6 months of enrollment Exclusion Criteria: Pregnant or breastfeeding Acute active pancreatitis Complicated pancreatic cysts Subjects who do not speak English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albumin bound paclitaxel<br>Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure. | Drug: Albumin bound paclitaxel<br>* Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.<br>* Other names: Abraxane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Pancreatitis | Safety of injection of albumin-bound paclitaxel will be measured by the frequency of pancreatitis. | 3-10 months (median 6 months) after injection therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts | The feasibility of the procedure will be measured by the ease of injection of albumin-bound paclitaxel into the cyst cavity across the gastro-duodenal wall. On a subjective scale, the endoscopist will note the ease of the procedure on a scale of 0-5, with 5 being very easy and 0 is not possible. Any score less than 2 will be considered unacceptable and failure of the study. | immediately after procedure | 
| Size of Cystic Lesion | Determine the size of the cystic lesion using CT scanning. Number of participants with reduction in size, persistent size, or increase in size of cyst are reported. | 3-10 months (median 6 months) after injection therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premalignant, Malignant