Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding

NCT00389935 | Completed Phase 2 DMC

• 1 other identifier: 00198
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Arteriovenous Malformation; Hereditary Hemorrhagic Telangiectasia; Hematochezia; Melena

Keywords

Gastrointestinal Bleeding; Arteriovenous Malformation; Angiodysplasia; Hereditary Hemorrhagic Telangiectasia; Obscure Bleeding

Outcome Measures

Primary Outcomes (1)

• Blood Transfusion requirements

  6 months

Secondary Outcomes (1)

• Hemoglobin overall complication rate Constipation Neuropathy

  6 month

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: Thalidomide

Interventions

Thalidomide DRUG

Thalidomide 50 - 200 mg once at nightime

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northport Veterans Affairs Medical Center: lead
• Augusta University: collaborator
• University of Massachusetts, Worcester: collaborator

Study Sites (3)

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Northport VAMC

Northport, New York, 11768, United States

Location

MeSH Terms

Conditions

Arteriovenous Malformations; Telangiectasia, Hereditary Hemorrhagic; Gastrointestinal Hemorrhage; Melena; Angiodysplasia

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemostatic Disorders; Telangiectasis; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Atul Kumar, MD

  Northport VAMC

  PRINCIPAL INVESTIGATOR

• James Gossage, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: October 17, 2006
• First Posted: October 19, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 2, 2011

Record last verified: 2011-07

Locations

US (3)