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Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding


Phase 2
18 Years
N/A
Not Enrolling
Both
Arteriovenous Malformation, Hereditary Hemorrhagic Telangiectasia, Hematochezia, Melena

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Trial Information

Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Blood Transfusion requirements

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Atul Kumar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northport VAMC

Authority:

United States: Food and Drug Administration

Study ID:

00198

NCT ID:

NCT00389935

Start Date:

October 2006

Completion Date:

July 2011

Related Keywords:

  • Arteriovenous Malformation
  • Hereditary Hemorrhagic Telangiectasia
  • Hematochezia
  • Melena
  • Gastrointestinal Bleeding
  • Arteriovenous Malformation
  • Angiodysplasia
  • Hereditary Hemorrhagic Telangiectasia
  • Obscure Bleeding
  • Congenital Abnormalities
  • Arteriovenous Malformations
  • Aneurysm
  • Hemangioma
  • Gastrointestinal Hemorrhage
  • Hemorrhage
  • Melena
  • Telangiectasia, Hereditary Hemorrhagic
  • Telangiectasis

Name

Location
Medical College of Georgia Augusta, Georgia  30912
UMass Memorial Medical Center Worcester, Massachusetts  01655
Northport VAMC Northport, New York  11768