Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis

Chronic Pancreatitis Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00469703
• Other study ID #: Chronic Pancreatitis
• Status: Terminated
• Phase: Phase 2
• First received: May 3, 2007
• Last updated: January 10, 2008
• Start date: August 2005
• Est. completion date: November 2007

Study information

• Verified date: January 2008
• Source: Winthrop University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Drug:
• Thalidomide

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Winthrop University Hospital	Celgene Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy
Secondary	reduction of frequency of hospitalizations
Secondary	quality of life
Secondary	reduction of pain