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Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT00469703
Recruitment Status : Terminated (Terminated)
First Posted : May 4, 2007
Last Update Posted : January 16, 2008
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Winthrop University Hospital

Study Description
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Brief Summary:
The purpose of this study is to determine if Thalidomide (Thalomid) is effective in treating patients with chronic pancreatitis.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Drug: Thalidomide Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2005
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
Drug Information available for: Thalidomide

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Safety and efficacy

Secondary Outcome Measures :
  1. reduction of frequency of hospitalizations
  2. quality of life
  3. reduction of pain

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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): NCT00469703


Sponsors and Collaborators
Winthrop University Hospital
Celgene Corporation
Investigators
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Principal Investigator: James H Grendell, MD Winthrop University Hospital
More Information
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ClinicalTrials.gov Identifier: NCT00469703    
Other Study ID Numbers: Chronic Pancreatitis
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: January 16, 2008
Last Verified: January 2008
Keywords provided by Winthrop University Hospital:
Pancreatitis
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents