Phase II Pilot Study of Octreotide, a Somatostatin Octapeptide Analog, for Gastrointestinal Hemorrhage in Hormone-Refractory Hereditary Hemorrhagic Telangiectasia and Senile Ectasia

National Center for Research Resources (NCRR)8 enrolled

Overview

OBJECTIVES: I. Evaluate the efficacy of octreotide, a somatostatin octapeptide analog, in decreasing gastrointestinal bleeding in patients with hormone-refractory hereditary hemorrhagic telangiectasia or senile ectasia.

PROTOCOL OUTLINE: Patients are treated with subcutaneous injections of octreotide twice a day. The dose is adjusted based on response. If there is no requirement for transfusions or intravenous iron for 4 weeks and the hemoglobin is greater than 10 mg/dL, therapy is continued for 1 year. If there is no decrease in bleeding after 10 weeks, the patient is removed from study.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Hereditary Hemorrhagic Telangiectasia Ectasia

Interventions

octreotideDRUG

Eligibility

Sex: ALLMin age: 0 Years

Medical Language ↔ Plain English

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Hereditary hemorrhagic telangiectasia or senile ectasia Refractory to or unable to tolerate hormonal therapy, i.e.: Estrogen Progesterone Danazol Gastrointestinal (GI) hemorrhage requiring transfusion within past 3 months Recurrent GI bleeding over more than 1 year At least 4 units packed RBCs transfused within past year OR intravenous iron required more than 4 times within past year No other likely source of hemorrhage determined within past year --Prior/Concurrent Therapy-- Disease hormone-refractory --Patient Characteristics-- No octreotide sensitivity

Data from ClinicalTrials.gov

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