Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis

This study has been terminated.
(Terminated)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT00469703
First received: May 3, 2007
Last updated: January 10, 2008
Last verified: January 2008
  Purpose

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


Condition Intervention Phase
Chronic Pancreatitis
Drug: Thalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • Safety and efficacy

Secondary Outcome Measures:
  • reduction of frequency of hospitalizations
  • quality of life
  • reduction of pain

Estimated Enrollment: 10
Study Start Date: August 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469703

Sponsors and Collaborators
Winthrop University Hospital
Celgene Corporation
Investigators
Principal Investigator: James H Grendell, MD Winthrop University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00469703     History of Changes
Other Study ID Numbers: Chronic Pancreatitis
Study First Received: May 3, 2007
Last Updated: January 10, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Winthrop University Hospital:
Pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014