Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis

• Status: Terminated
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Winthrop University Hospital
• Collaborator: Celgene Corporation
• Treatments: Thalidomide

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 Patients will be withdrawn from the study at Visit 4 (Month 3) if pain score on VAS scale has not improved.