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Endoscopic Abraxane Injection Into Pancreatic Cysts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01698710
Recruitment Status : Terminated (expiration of IRB approval)
First Posted : October 3, 2012
Results First Posted : June 21, 2017
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
William R. Brugge, MD, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cysts Drug: Albumin bound paclitaxel Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EUS Guided Injection of Albumin Bound Paclitaxel Into Pancreatic Cysts
Study Start Date : November 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
Drug Information available for: Paclitaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: Albumin bound paclitaxel
Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
 Drug: Albumin bound paclitaxel
Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
Other Name: Abraxane


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of Pancreatitis [ Time Frame: 3-10 months (median 6 months) after injection therapy ]
    Safety of injection of albumin-bound paclitaxel will be measured by the frequency of pancreatitis.


Secondary Outcome Measures :
  1. Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts [ Time Frame: immediately after procedure ]
    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.

  2. Size of Cystic Lesion [ Time Frame: 3-10 months (median 6 months) after injection therapy ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698710


Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: William Brugge, MD Massachusetts General Hospital
More Information
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Responsible Party: William R. Brugge, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01698710    
Other Study ID Numbers: 12-178
First Posted: October 3, 2012    Key Record Dates
Results First Posted: June 21, 2017
Last Update Posted: June 21, 2017
Last Verified: September 2014
Keywords provided by William R. Brugge, MD, Massachusetts General Hospital:
Premalignant
Malignant
Additional relevant MeSH terms:
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Cysts
Pancreatic Cyst
Neoplasms
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases
Paclitaxel
 Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action