Overview

Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding

Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether Thalidomide is effective in the treatment of arteriovenous malformations in the gastrointestinal tract.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Northport Veterans Affairs Medical Center
Collaborators:
Augusta University
University of Massachusetts, Worcester
Treatments:
Thalidomide
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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