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Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis

Primary Purpose

Chronic Pancreatitis

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
Winthrop University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pancreatitis focused on measuring Pancreatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-75, inclusive.
  2. Female must be post menopausal (≥ 24 months without menses or surgically sterilized).
  3. Able to comprehend English.
  4. Chronic pancreatic pain lasting for more than 2 months.

  5. History of chronic pancreatitis with pancreatic type pain confirmed by at least one of the following:

    • Histological confirmation
    • CT/MRI (including calcifications, dilated cuts, dilated MPD, and /or atrophy)
    • ERCP with Cambridge score of 2 or greater
  6. Subject must score at least 4 cm on the VAS scale during the 1-2 week lead-in-period.
  7. Patients must give written informed consent.
  8. Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program.

Exclusion Criteria:

  1. Female of child-bearing potential.
  2. Unable to comprehend English.
  3. Patients with diabetes requiring insulin.
  4. Evidence of gallstones on screening ultrasonography.
  5. Current alcohol abuse or addiction to opiate analgesics.
  6. Patients with existing peripheral neuropathy.
  7. Patients who are taking medications known to be associated with development of neuropathy: Amiodarone, hydralazine, perhexiline, vincristine, cisplatin, Metronidazole (Flagyl), Dapsone, Phenytoin and Disulfiram.
  8. Patients who have pre-existing hypercoagulable state. Patients with a history of malignancy within the past 5 years, patients with a recent surgical procedure, patients with chronic immobilization causing blood stasis, patients with history of embolism or deep vein thrombosis, patients with extreme heart failure, and patients with a congenital disorder of the clotting cascade.
  9. Patients with active alcoholic liver disease or elevated liver function >3Xs the upper limit of normal.
  10. Patients will be withdrawn from the study at Visit 4 (Month 3) if pain score on VAS scale has not improved.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Safety and efficacy

    Secondary Outcome Measures

    reduction of frequency of hospitalizations
    quality of life
    reduction of pain

    Full Information

    First Posted
    May 3, 2007
    Last Updated
    January 10, 2008
    Sponsor
    Winthrop University Hospital
    Collaborators
    Celgene Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00469703
    Brief Title
    Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis
    Official Title
    A Phase II, Open-Label, Single Center Pilot Study to Determine the Safety and Efficacy of THALOMID (Thalidomide) in Patients With Chronic Pancreatitis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Terminated
    Why Stopped
    Terminated
    Study Start Date
    August 2005 (undefined)
    Primary Completion Date
    November 2007 (Actual)
    Study Completion Date
    November 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Winthrop University Hospital
    Collaborators
    Celgene Corporation

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if Thalidomide (Thalomid) is effective in treating patients with chronic pancreatitis.
    Detailed Description
    Pancreatitis is an inflammation of the pancreas, a gland that lies behind the stomach. The inflammation may develop suddenly (acute pancreatitis) or over many years (chronic pancreatitis). The pancreas produces the hormones, insulin and glucagon to control metabolism. The hormones and enzymes flow from the pancreas through the pancreatic duct into the upper part of the small intestine. Most chronic pancreatitis patients often experience chronic abdominal pain during the course of the disease. Thalidomide increased the production of interleukin-10 (IL-10), which is important in regulating intestinal inflammation. Thalidomide is approved by the Food and Drug Administration (FDA) for a leprosy skin condition, erythema nodosum lerosum (ENL), but not for the treatment of chronic pancreatitis. In this case it is considered experimental.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pancreatitis
    Keywords
    Pancreatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Thalidomide
    Primary Outcome Measure Information:
    Title
    Safety and efficacy
    Secondary Outcome Measure Information:
    Title
    reduction of frequency of hospitalizations
    Title
    quality of life
    Title
    reduction of pain

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-75, inclusive. Female must be post menopausal (≥ 24 months without menses or surgically sterilized). Able to comprehend English. Chronic pancreatic pain lasting for more than 2 months. History of chronic pancreatitis with pancreatic type pain confirmed by at least one of the following: Histological confirmation CT/MRI (including calcifications, dilated cuts, dilated MPD, and /or atrophy) ERCP with Cambridge score of 2 or greater Subject must score at least 4 cm on the VAS scale during the 1-2 week lead-in-period. Patients must give written informed consent. Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program. Exclusion Criteria: Female of child-bearing potential. Unable to comprehend English. Patients with diabetes requiring insulin. Evidence of gallstones on screening ultrasonography. Current alcohol abuse or addiction to opiate analgesics. Patients with existing peripheral neuropathy. Patients who are taking medications known to be associated with development of neuropathy: Amiodarone, hydralazine, perhexiline, vincristine, cisplatin, Metronidazole (Flagyl), Dapsone, Phenytoin and Disulfiram. Patients who have pre-existing hypercoagulable state. Patients with a history of malignancy within the past 5 years, patients with a recent surgical procedure, patients with chronic immobilization causing blood stasis, patients with history of embolism or deep vein thrombosis, patients with extreme heart failure, and patients with a congenital disorder of the clotting cascade. Patients with active alcoholic liver disease or elevated liver function >3Xs the upper limit of normal. Patients will be withdrawn from the study at Visit 4 (Month 3) if pain score on VAS scale has not improved.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James H Grendell, MD
    Organizational Affiliation
    Winthrop University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis

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