Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding
Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding
The purpose of this study is to determine whether Thalidomide is effective in the treatment
 of arteriovenous malformations in the gastrointestinal tract.
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). Repeated episodes of gastrointestinal bleeding (GIB), especially in the
 elderly have been attributed to angiodysplasia. Clinically significant GIB may be also seen
 in up to 40% of HHT patients, usually in the fourth and fifth decades of life. GIB may
 manifest both as acute major hemorrhage, slow intermittent blood loss or a combination of
 these findings and patients may be symptomless, present with acute bleeding or iron
 deficiency anemia. Recurrent hemorrhage and persistent iron-deficiency anemia is common
 despite supplemental iron therapy and patients require repeated transfusions. Amongst
 patients with preexisting co-morbidities, repeated bleeding may lead to significant morbidity
 and mortality. Furthermore, re-bleeding among these patients consumes a disproportionate
 share of healthcare resources devoted to multiple admissions, repeated endoscopies and blood
 transfusions. There are no effective treatment options available currently. The purpose of
 this study is to determine whether Thalidomide is effective in the treatment of arteriovenous
 malformations in the gastrointestinal tract.
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