Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding

Completed · Phase 2

Conditions studied: Arteriovenous Malformation, Hereditary Hemorrhagic Telangiectasia, Hematochezia, Melena

In brief

The purpose of this study is to determine whether Thalidomide is effective in the treatment of arteriovenous malformations in the gastrointestinal tract.

Key facts

Study ID

NCT00389935

Run by

Northport Veterans Affairs Medical Center

People needed

14

Starts

2006-10-01

Expected to finish

2011-07-01

Last updated by the study team

2011-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Medical College of Georgia — Augusta, Georgia, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• Northport VAMC — Northport, New York, United States

Full record on ClinicalTrials.gov

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