Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding (TAG)

This study has been completed.
Sponsor:
Collaborators:
Georgia Regents University
University of Massachusetts, Worcester
Information provided by:
Northport Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00389935
First received: October 17, 2006
Last updated: August 1, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Arteriovenous Malformation
Hereditary Hemorrhagic Telangiectasia
Hematochezia
Melena
Drug: Thalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding

Resource links provided by NLM:


Further study details as provided by Northport Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Blood Transfusion requirements [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hemoglobin overall complication rate Constipation Neuropathy [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: October 2006
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: Thalidomide
Thalidomide 50 - 200 mg once at nightime

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). 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389935

Locations
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, New York
Northport VAMC
Northport, New York, United States, 11768
Sponsors and Collaborators
Northport Veterans Affairs Medical Center
Georgia Regents University
University of Massachusetts, Worcester
Investigators
Principal Investigator: Atul Kumar, MD Northport VAMC
Principal Investigator: James Gossage, MD Georgia Regents University
  More Information

No publications provided

Responsible Party: Atul Kumar, US Veterans Affairs Medical Center Northport
ClinicalTrials.gov Identifier: NCT00389935     History of Changes
Other Study ID Numbers: 00198
Study First Received: October 17, 2006
Last Updated: August 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Northport Veterans Affairs Medical Center:
Gastrointestinal Bleeding
Arteriovenous Malformation
Angiodysplasia
Hereditary Hemorrhagic Telangiectasia
Obscure Bleeding

Additional relevant MeSH terms:
Telangiectasia, Hereditary Hemorrhagic
Arteriovenous Malformations
Congenital Abnormalities
Gastrointestinal Hemorrhage
Hemangioma
Telangiectasis
Cardiovascular Abnormalities
Cardiovascular Diseases
Digestive System Diseases
Gastrointestinal Diseases
Hematologic Diseases
Hemorrhage
Hemorrhagic Disorders
Hemostatic Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Pathologic Processes
Vascular Diseases
Vascular Malformations
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on October 23, 2014