Clinical trial NCT01698710: Endoscopic Abraxane Injection Into Pancreatic Cysts
Official title: EUS Guided Injection of Albumin Bound Paclitaxel Into Pancreatic Cysts
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatic Cysts
Keywords: Premalignant
Malignant
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of Pancreatitis
timeFrame: 3-10 months (median 6 months) after injection therapy
Secondary outcomes:
measure: Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts
timeFrame: immediately after procedure
measure: Size of Cystic Lesion
timeFrame: 3-10 months (median 6 months) after injection therapy
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: William Brugge, MD
role: PRINCIPAL_INVESTIGATOR
References: