Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis

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

Tracking Information

• First Submitted Date: May 3, 2007
• First Posted Date: May 4, 2007
• Last Update Posted Date: January 16, 2008
• Study Start Date: August 2005
• Actual Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 3, 2007): Safety and efficacy
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 3, 2007)

• reduction of frequency of hospitalizations
• quality of life
• reduction of pain

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Pancreatitis
• Intervention: Drug: Thalidomide
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Estimated Enrollment (submitted: May 3, 2007): 10
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 2007
• Actual Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00469703
• Other Study ID Numbers: Chronic Pancreatitis
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Winthrop University Hospital
• Collaborators: Celgene Corporation

Investigators

• Principal Investigator: James H Grendell, MD; Winthrop University Hospital

• PRS Account: Winthrop University Hospital
• Verification Date: January 2008