Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis

January 10, 2008 updated by: Winthrop University Hospital

A Phase II, Open-Label, Single Center Pilot Study to Determine the Safety and Efficacy of THALOMID (Thalidomide) in Patients With Chronic Pancreatitis.

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

10

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety and efficacy

Secondary Outcome Measures

Outcome Measure
quality of life
reduction of frequency of hospitalizations
reduction of pain

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Winthrop University Hospital

Collaborators

Celgene Corporation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

May 3, 2007

First Submitted That Met QC Criteria

May 3, 2007

First Posted (Estimate)

May 4, 2007

Study Record Updates

Last Update Posted (Estimate)

January 16, 2008

Last Update Submitted That Met QC Criteria

January 10, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chronic Pancreatitis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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