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Treatment With Octreotide in Patients With Lymphangioleiomyomatosis

Yalnız qeydiyyatdan keçmiş istifadəçilər məqalələri tərcümə edə bilərlər
Giriş / Qeydiyyatdan keçin
Bağlantı panoya saxlanılır
StatusTamamlandı
Sponsorlar
National Heart, Lung, and Blood Institute (NHLBI)

Açar sözlər

Mücərrəd

Lymphangioleiomyomatosis (LAM), a disease primarily of women of child-bearing age, is characterized by cystic lung disease and abdominal tumors (e.g., angiomyolipomas). Within the LAM patient population is a subset of patients who develop chylous effusions and lymphangioleiomyomas. Treatment of many of these symptoms has been ineffective. Previous studies with somatostatin and octreotide in other clinical settings have shown reduction in chylous effusions. This study assesses the effectiveness of octreotide in symptomatic patients with LAM, lymphangioleiomyomas and/or chylous effusions/ascites, peripheral lymphedema and chyluria.

Təsvir

Lymphangioleiomyomatosis (LAM), a disease primarily of women of child-bearing age, is characterized by cystic lung disease and abdominal tumors (e.g., angiomyolipomas). Within the LAM patient population is a subset of patients who develop chylous ascites, chylous pleural effusions, chyluria, peripheral lymphedema, and/or lymphangioleiomyomas. Lymphangioleiomyomas are believed to result from a proliferation of abnormal smooth muscle cells within the lymphatic system, which appears to obstruct fluid outflow, leading to fluid accumulation and an increase in size. The lymphangioleiomyomas may occur anywhere along the axial lymphatic chain. In patients with LAM, they occur most frequently in the thorax, abdomen and pelvis and may give rise to a myriad of symptoms (e.g., paresthesias, palpitations, peripheral edema). In some patients, treatment of many of these symptoms, i.e., elevation of lower extremities, paracentesis, thoracentesis, diuretics, and/or surgery, has been ineffective. Previous studies with somatostatin and octreotide in other clinical settings (e.g., traumatic damage to the lymphatics) have shown a successful reduction in chylous effusions, chyluria, ascites, and peripheral lymphedema, when other therapies were less effective. This study will assess the effectiveness of octreotide in symptomatic patients with LAM, lymphangioleiomyomas and/or chylous effusions/ascites, peripheral lymphedema and chyluria. The dose of octreotide starts at 50 micrograms (ug) by the subcutaneous route twice a day. After two weeks the dose will be increased to 200 ug per day and two weeks later to 400 ug/day. Maximal dose is 400 ug twice a day.

Tarixlər

Son Doğrulandı: 03/31/2010
İlk təqdim: 06/08/2000
Təxmini qeydiyyat təqdim edildi: 06/08/2000
İlk Göndərmə: 06/11/2000
Son Yeniləmə Göndərildi: 04/28/2010
Son Yeniləmə Göndərildi: 04/29/2010
İlk təqdim edilmiş nəticələrin tarixi: 02/25/2010
İlk təqdim edilmiş QC nəticələrinin tarixi: 04/28/2010
İlk göndərilən nəticələrin tarixi: 04/29/2010
Həqiqi Təhsilin Başlama Tarixi: 05/31/2000
Təxmini İlkin Tamamlanma Tarixi: 03/31/2008

Vəziyyət və ya xəstəlik

Lymphangioleiomyomatosis
Lymphangiomyomas
Pleural Effusions
Ascites

Müdaxilə / müalicə

Drug: Octreotide

Faza

Faza 2

Qol Qrupları

QolMüdaxilə / müalicə
Experimental: Octreotide
Patients with lymphangioleiomyomatosis and lymphatic tumors, ascites or pleural effusions who are symptomatic will receive subcutaneous injections of octreotide starting at a dose of 100 micrograms per day. Doses will be gradually increased to a maximum of 800 micrograms per day, two months after enrollment, if there is no response to lower doses.
Drug: Octreotide
Treatment with octreotide starts at a dose of 50 micrograms(ug) twice a day which is increased to 100 ug twice a day after two weeks and to 200 ug twice a day two weeks later. After two months, if there is no response the dose shall be increased to 400 ug twice a day.

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar 18 Years Üçün 18 Years
Təhsilə Uyğun CinslərFemale
Sağlam Könüllüləri qəbul edirBəli
Kriteriyalar

- INCLUSION CRITERIA:

Patients enrolled in the lymphangioleiomyomatosis natural history protocol who have symptoms associated with one of the following:

1. lymphangioleiomyomas

2. chylous pleural effusions

3. peripheral lymph-edema

4. chyloptysis

5. protein-losing enteropathy

6. chyluria

Patients will be included in this protocol if symptoms are attributed to the above processes. Patients with malabsorption disorders, diabetes, hypo/hyperthyroidism, or other endocrine-related disorders will be included if justified clinically based on severity of symptoms.

EXCLUSION CRITERIA:

1. Hypersensitivity to somatostatin, octreotide or its analogues

2. Patients with hepatitis B, hepatitis C, or other clinically significant liver diseases

3. Transplant patients

4. Pregnant women or women who are beast-feeding

5. Patient or another responsible party is unable to give the subcutaneous injection

6. Patient unwilling to be followed per the guidelines set forth

7. Patients with decreased renal function (creatinine greater than 1.5)

8. Patients with HIV infection

9. Immunosuppressed patients

Nəticə

İlkin nəticə tədbirləri

1. Number of Participants With a Reduction in Total Tumor Volume of at Least 20%. [Six months]

Octreotide treatment will be considered successful if the patient receiving treatment for six months shows a reduction in total tumor mass/ fluid collection or reaccumulation of at least 20%.

2. Number of Participants With a Reduction of Pain/Symptoms as Measured by a Simple Numeric Symptom Distress Scale (NDS) to Rate the Severity of Individual Symptoms. [Six months]

Octreotide treatment will be considered successful if the reported pain/symptom score is reduced by at least 2 levels at termination of treatment. A simple visual numeric distress scale ranging from zero to 10 will be employed to rate the severity of individual symptoms. The best score is zero, which means absence of symptoms and the maximal is 10, meaning that the symptoms are very severe.

İkincili Nəticə Tədbirləri

1. Number of Participants With Liver Function Abnormalities [Six months]

One or more abnormality of the following liver function tests: Alkaline phosphatase above 116 i.u. SGPT above 41 i.u. SGOT from 34 i.u. Total bilirubin above 1.0 mg/dl

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