Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding (TAG)
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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 |
- Blood Transfusion requirements [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 |
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| 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 | |
| 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:
|
Congenital Abnormalities Arteriovenous Malformations Aneurysm Hemangioma Gastrointestinal Hemorrhage Hemorrhage Melena Telangiectasia, Hereditary Hemorrhagic Telangiectasis Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Vascular Diseases Neoplasms, Vascular Tissue Neoplasms by Histologic Type |
Neoplasms Gastrointestinal Diseases Digestive System Diseases Pathologic Processes Hemostatic Disorders Hemorrhagic Disorders Hematologic Diseases Thalidomide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 16, 2013