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Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding (TAG)

Primary Purpose

Arteriovenous Malformation, Hereditary Hemorrhagic Telangiectasia, Hematochezia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Thalidomide

About this trial

This is an interventional treatment trial for Arteriovenous Malformation focused on measuring Gastrointestinal Bleeding, Arteriovenous Malformation, Angiodysplasia, Hereditary Hemorrhagic Telangiectasia, Obscure Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical College of Georgia
UMass Memorial Medical Center
Northport VAMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

Blood Transfusion requirements

Secondary Outcome Measures

Hemoglobin overall complication rate Constipation Neuropathy

Full Information

NCT ID

NCT00389935

First Posted

October 17, 2006

Last Updated

August 1, 2011

Sponsor

Northport Veterans Affairs Medical Center

Collaborators

Augusta University, University of Massachusetts, Worcester

1. Study Identification

Unique Protocol Identification Number

NCT00389935

Brief Title

Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding

Acronym

TAG

Official Title

Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Northport Veterans Affairs Medical Center

Collaborators

Augusta University, University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arteriovenous Malformation, Hereditary Hemorrhagic Telangiectasia, Hematochezia, Melena

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Thalidomide

Intervention Description

Thalidomide 50 - 200 mg once at nightime

Primary Outcome Measure Information:

Title

Blood Transfusion requirements

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Hemoglobin overall complication rate Constipation Neuropathy

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Atul Kumar, MD

Organizational Affiliation

Northport VAMC

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

James Gossage, MD

Organizational Affiliation

Augusta University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical College of Georgia

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

UMass Memorial Medical Center

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

Northport VAMC

City

Northport

State/Province

New York

ZIP/Postal Code

11768

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding

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