Status:
COMPLETED
Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding
Lead Sponsor:
Northport Veterans Affairs Medical Center
Collaborating Sponsors:
Augusta University
University of Massachusetts, Worcester
Conditions:
Arteriovenous Malformation
Hereditary Hemorrhagic Telangiectasia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether Thalidomide is effective in the treatment of arteriovenous malformations in the gastrointestinal tract.
Detailed Description
Arteriovenous malformations (AVM's) are the commonest vascular abnormalities of the gut. AVM's or Angiodysplasia may be acquired or inherited as in a hereditary hemorrhagic telangiectasia (HHT). Repea...
Eligibility Criteria
Inclusion
- Patients must be 18 years of age or older
- Patient must have had greater than 2 episodes of overt bleeding over last 2 years requiring \> 4 units of PRBC for bleeding 20 AVM. AVM's should have been identified at optical/capsule endoscopy or angiography.
- Patients must have adequate hematologic, renal and liver function (i.e. Platelets ≥ 100,000/mm3, Creatinine ≤ 1.7mg/dl, Total Bilirubin ≤ 2.5mg/dl, Transaminases ≤ 4 times above the upper limits of the institutional norm)
- Patients must be able to provide written informed consent. Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods (described in detail under thalidomide drug information section) to avoid conception. Women of child-bearing potential must have a negative pregnancy test prior to treatment on this protocol. Men taking thalidomide must agree to use latex condoms every time they have sex with women since it has been shown that thalidomide is found in semen. All patients must agree to participate in the S.T.E.P.S.® program (System for Thalidomide Education and Prescribing Safety). All patients must be educated under the requirements of the S.T.E.P.S.® program. Patients are required to complete a S.T.E.P.S.® survey and sign and additional consent form indicating that they understand all information provided to them as part of the S.T.E.P.S.® educational counseling.
- Estimated life expectancy must be greater than 2 months.
Exclusion
- Pregnant and/ or lactating female
- Personal history of thromboembolic disease
- History of seizure activity
- History of neoplasm except basal cell carcinoma in-situ
- History of severe neuropathies
- Women of child bearing potential
- Inability to comply with the protocol
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00389935
Start Date
October 1 2006
End Date
July 1 2011
Last Update
August 2 2011
Active Locations (3)
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1
Medical College of Georgia
Augusta, Georgia, United States, 30912
2
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
3
Northport VAMC
Northport, New York, United States, 11768