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.

Condition	Treatment or Intervention	Phase
Hereditary Hemorrhagic Telangiectasia Ectasia	Drug: octreotide	Phase II

Further Study Details: 

Expected Total Enrollment:  8

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.

Genders Eligible for Study:  Both

Criteria

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

Study chairs or principal investigators

Joshua R. Korzenik,  Study Chair,  Yale University   

Study ID Numbers:  199/11875; YALESM-7893
Record last reviewed:  June 2000
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004327
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08